Location: Rockville, MD
Company: Emergent Biosolutions
Manager, Quality Systems is responsible for management and oversight of personnel and quality systems by networking with internal and external stakeholders to positively influence the compliance health of the company. This is a key role which contributes to the continuous improvement of quality and compliance at the Rockville site.
ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Serve as the Subject matter Expert on site Quality Systems and provide guidance and interpretation to internal stakeholders. Manage the generation, execution and technical review of data and documentation, ensuring that they
are maintained in compliance with FDA regulations, global regulations, and Emergent internal directives. Lead preparations for internal, external, and other regulatory agency inspections (FDA, EMU, etc.
). Manage resolution for both audit and inspection findings. Oversee and manage site’s Quality Risk Management Systems to ensure proper follow up and closure of identified risks. Collaborate with other impacted Emergent’s sites and functions to ensure identified gaps from emerging regulations are addressed. Review and approve compliance documentation such as procedures, contracts, audit reports and quality agreements. Lead and manage the CAPAs, Deviations, Change Controls, Audits and Supplier
Quality Management program. Responsible for timely completion of compliance, change controls and CAPA commitments.
Develop and implement procedures for compliant and effective Quality Management Systems. Streamline processes and effectively utilize tools and resources to improve site compliance. Establish, track and present Quality Metrics to support Quality Management Review. Participate as Quality Assurance representative on various project teams with impact to compliance and/or the Quality Systems. Support the Quality team during deviation/formal investigations, including participating in root cause analysis activities, document review and verification, determination of corrective/preventive action and backssment of product impact.
Maintain current knowledge of industry standards and regulatory requirements. Management All functions associated with recruitment and hiring process for department Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts. Mentor, train and develop team members. Define resource requirements, plans, and prioritize resources. Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable Mentor, coach, challenge, and develop team members while serving as a role model of Emergent’s core values Ensure the team effectively collaborates with key internal and external stakeholders, in accordance with our corporate values and practices The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.
Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Education : BA/BS degree, preferably in a life science related discipline, or equivalent work experience. Experience : Minimum of 6 years of experience working in an FDA regulated industry including participation in agency inspections. Highly desirable to have minimum of 4 years of management experience. Demonstrated experience leading a staff through mentoring and coaching in support of business needs, evaluating performance and proactive handling of employee relations.
Previous experience working with FDA and participating in regulatory agency inspections. Previous experience in management of Quality Systems. Previous experience operating within Quality Systems such as: Deviation, CAPA, and Change Control. Knowledge : Must possess strong c GMP knowledge across Compliance functions. Must have competence of c GMPs, 21CFR, and up to date knowledge of regulatory guidance and expectations. In-depth working knowledge of Veeva Document System and SAP preferred. Skills : Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
Must have SOP, investigation, change control/corrective action, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents. Must have excellent verbal and written communication skills and the ability to successfully manage without authority in a cross-functional matrixed environment. Abilities : Demonstrated capabilities (e. g. able to translate strategy to action, Effective verbal and/or written communicate at all levels of organization, work effectively in ambiguous situations, ability to multi-task, proven track record of increasing customer base) Must be able to critically evaluate data summaries and conclusions.
Must be able to prepare reports for internal metrics and technical content. Ability to exercise judgment within defined practices and policies by selecting methods and techniques for obtaining solutions including strategic CAPA. Ability to work in a team environment as the quality representative with both internal and external customers. Must have strong attention to detail. Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees.
This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent Bio Solutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.
Emergent does not discriminate on the basis of race, color, creed, religion, interaction or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), interactionual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent Bio Solutions for activities related to your prospective employment. Emergent Bio Solutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy. Emergent Bio Solutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent Bio Solutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent Bio Solutions by search/recruiting agencies not already on Emergent Bio Solutions’ approved agency list shall become the property of Emergent Bio Solutions and if the candidate is subsequently hired by Emergent Bio Solutions, Emergent Bio Solutions shall not owe any fee to the submitting agency.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs encompass a range of high-level positions within organizations, typically involving the responsibility for strategic planning, decision-making, and leading teams or entire departments. Individuals in these roles are expected to possess strong leadership skills, the ability to think critically and strategically, as well as excellent communication abilities. Executives often have a significant influence on company culture, operations, and financial success. These roles include titles such as CEO, CFO, COO, Managing Director, as well as various managerial positions across different departments such as sales, marketing, human resources, and more.
Memory Support Assisted Living Apartments and 45 Skilled Nursing beds. We have a proven record of success! IKF consistently maintains a 5 Star CMS rating and we are CARF certified! We have achieved certification as a Great Place to Work based on team member feedback in areas relating to trust, culture, and the meaning derived from their jobs and we are SAGE Certified.
Ingleside offers competitive salaries and comprehensive benefit plans that include Medical, Dental and Vision, Paid Time Off (PTO), 401k with 3% matching after a year and 3-year vesting. We also offer onsite CPR, Well-being Model and Certified Dementia Practitioner training as well as Scholarship Opportunities up to $5000
in a year and an Employee Appreciation Award at the end of the year! Job Summary: This position is primarily responsible for managing the Cultural Arts activities and programing.
The position is responsible the developing, planning and executing cultural arts programs for Independent Living Residents. The position will collaborate with the IKF Cultural Arts Council in developing and planning and executing of recreational, social, and therapeutic activities for the residents. Job Requirements: Bachelor's degree in Arts and Theater or in Human Service field required, two (2) to five (5) years human service experience, or equivalent combination of education and experience. Incumbents should
be able to apply common sense understanding to carry out instructions furnished in written and oral form, possess high-quality verbal and written communication ability, strong interpersonal and organizational skills.
Be flexible to work on some weekends and evenings on events or shows. Must be proficient in the operation of computer applications such as Microsoft Office. Key Responsibilities: Plans and or leads programs for Life Enrichment Department. Develops, plans, and promotes programs for residents to include arts, outings, speakers, shows, etc. Schedules and assists in set up and/or clean-up of area for programs. Leads activity for residents as requested by the Independent Living Administrator and Cultural Arts Council.
Attends committee meetings. Administrative Responsibilities : Tracks programs results including resident participation, ideas, and feedback. Keeps records of all programs. Aids in yearly budget planning. Creates program ideas and obtains approval from the Independent Living Administrator. Schedules outside trips and coordinates travel accommodations with the Transportation Coordinator. Submits monthly special event forms to Dining. Submits monthly room set-up sheets to Housekeeping Department. Supervisory Responsibility: Acts as a leader and manager of assigned positions; ensuring productivity, efficiency and accuracy in work performed.
Ensures initial and on-going training is provided to volunteers as needed; ensures cross-training is completed as appropriate. Identifies unacceptable performance and behavior exhibited by volunteers and takes appropriate action; utilizes progressive discipline policy when appropriate and maintains documentation as required. Assures that volunteers follow established policies and procedures at all times. Screens and interviews volunteers on an as needed basis. Maintains resident confidentiality and privacy at all times according to policies and procedures; uses discretion when discussing confidential matters.
Demonstrates courteous and cooperative behavior with residents, families, co-workers, subordinates, supervisors, and other department staff. Maintains positive working relationships with management and coworkers; willingly follows directions and requests as appropriate. Exhibits professional standards through appearance and demeanor consistent personnel standards. Demonstrates a thorough knowledge of work assignments and performs in a manner to meet quality and timeliness objectives.
Demonstrates knowledge and understanding of policies and procedures; seeks clarification or interpretation from appropriate supervisor when needed. Participates in in-service, projects, or committees as assigned. Maintains all certifications necessary for employment. Demonstrates flexibility, open mindedness, and versatility in adjusting to changing environments and requirements as necessary. Commits to continually improving his/her skills through participations in education opportunities whether offered on the job, within, or outside of the community, to increase knowledge of work-related issues.
EEO Statement As an employer committed to Equal Employment Opportunity, Ingleside recruits, hires, and promotes qualified persons in all job classifications without regard to age, race, color, religion, interaction, interactionual orientation, gender, gender identity, gender expression, national origin, ethnic origin, disability, genetic information, covered veteran status, or any other basis protected by law. Job Posted by Applicant Pro
plan. In the primary contact role, the Strategic Accounts Manager builds account relationships from a service and economic perspective, ensuring high customer satisfaction with existing Avendra programs and offering greater penetration of Avendra offerings within the client organization, where applicable.
Position Reports to Dir, Account Management Job Responsibilities Primary Responsibilities Interface with Account Director, aligning all efforts in support of strategy and business goals outlined in the client plan. Understand client needs for changes to existing or new products and services and advocate/represent within Avendra to accomplish client goals. Maintain excellent relationships
with key client contacts at the corporate and regional offices and maintain awareness of key operational contacts at the property level. “Become trusted-advisor and important team member of the client corporate support team”.
Understand the roles of key contacts within the client organization. Develop and implement objectives to increase client’s participation with Avendra programs. Work with client leadership to implement participation plan improvements. Monitor Avendra program performance. Act as key on-site Avendra designate to resolve performance or service issues and capture Avendra ‘wins’ whereby the Avendra solution has demonstrated improvement. Quickly and actively assist in resolving
supplier issues on behalf of client. Actively assist with development and implementation of new initiatives and programs of client Facilitate discussions and issue resolution with appropriate internal Avendra departments on client’s behalf.
Educate on Avendra’s business model and value proposition. Provide client with reoccurring reporting, to include custom reporting as requested. Secondary Responsibilities Travel to regional meetings & client events as needed, to support the client and Avendra objectives as well as client’s usage of programs. Travel to key property locations for relationship development, implementation of key programs or issue resolution work might also be necessary.
Provide support for additional Accounts. Primary Competencies Planning and Organization Problem Solving & Analytical Skills Effective Written/Oral Communications Conflict Management Relationship Building Influencing Others (P3 and above) #FS-200 Qualifications Strong understanding of procurement/supply chain management in Hospitality segment Ability to establish and maintain strong working relationships The ability to use “good business judgement” and balance being an advocate for the client’s interests, Avendra and its contracted suppliers Ability to “make things happen”, either in troubleshooting role or in increasing the penetration of Avendra’s offerings where applicable Excellent written and verbal communication and organizational skills Strong analytical skills required, turning data into knowledge and knowledge into action Intermediate Excel skills, strong analytical skills, and presentation skills Ability to lead specific key complex projects Highly comfortable with ambiguity and firm confidentiality requirements Spanish speaking/writing would be a plus Overnight Travel Requirements.
Type: All modes of transportation, percentage up to 20%, depending on time of the year, length: 1-4 nights, depending on events Years of Relevant Experience.
5-8 years of experience Education Requirements. BS/BA in relevant field or equivalent years' experience About Aramark Our Mission Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, interaction, gender, pregnancy, disability, interactionual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law.
About Aramark The people of Aramark proudly serve millions of guests every day through food, facilities, and uniform services in 19 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth.
So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at http: // or connect with us on Facebook , Instagram and Twitter.
