Location: Westborough, MA
Company: Olympus
Our Purpose is to make people’s lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life. Job Description Responsible for the Clinical Quality Assurance (CQA) function of the organization, ensuring planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies conducted throughout Olympus.
Lead a team focusing on continuous improvement projects and compliance using approved tools, design control, validation, and ensuring adherence to the agency regulations and
standards, GCP, Industry guidelines, local regulations, and Olympus policies and processes for the conduct of clinical trials. This involves working closely with Clinical Affairs, Data Analytics and Management, and the Olympus Quality & Regulatory (QARA) function.
This role will have a direct link to the SVP Corporate Quality for quality standards management, escalations, and QMS processes. Job Duties Serve as the strategic leader and provide clinical expertise and oversight to ensure patient centricity through clinical quality assurance processes and activities. Direct, oversee, and manage the quality oversight of GCP activities (including development and maintenance of SOP/policy and
best practices, vendor management, data management, internal and external audit functions) to ensure patient safety and data integrity.
Provides expert leadership and strategic insight for the implementation and management of a clinical risk management program and supports global clinical audits and work with auditors to resolve any non-compliance(s) identified. Leads and delivers innovative clinical quality strategies and solutions through collaboration with business partners and other Quality and Compliance functions to support effective and timely solutions to compliance issues and/or questions. Provide input and expertise for clinical vendor qualifications.
Partner with clinical internal stakeholders to manage clinical vendor oversight and software validation activities. Supports GCP health authority audits and inspections and provides GCP compliance technical support during inspections of investigator sites. Participate in regulatory agency inspections. Represent CQA in Program Teams, sub-teams and study teams where relevant and provide input, guidance, and oversight to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements. Plan/strategize inspection readiness activities to support program/study team.
Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and Olympus policies and procedures by continuous evaluation of clinical processes through CQA oversight activities. Interfaces with Quality and Compliance to ensure audit strategies are effectively executed. Advances the Olympus Quality System through leading development and implementation of systems and processes required to support global quality assurance requirements. Drives development and continuous improvement of necessary clinical systems to assure compliance to worldwide regulations and corporate policies.
Analyzes and acts upon clinical audit data and emerging regulatory intelligence to demonstrate appropriate CQA supervision of the compliance of Olympus clinical development systems, processes and procedures. Supports clinical inspections onsite or remotely to ensure inspections are a success. Job Qualifications Required : University/bachelor's degree or equivalent required; Degree must be in a Science (BS) field. A master’s degree strongly preferred. Minimum of 10 years of professional related work experience.
Experience in the global medical or biotech industry must. Minimum of 5 years of people management experience & proven leadership. Other Considerations (travel/hours availability, etc. ): Less than 10% Travel Requirement Preferred: Must have extensive knowledge of worldwide Clinical Regulations and Guidelines Experience in successfully managing Health Authority Inspections Proven track record in developing and implementing quality systems and processes in a clinical setting. Excellent verbal, written and presentation skills to effectively communicate with all levels of management. Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Excellent leadership skills with the ability to influence and collaborate effectively across cross-functional teams. Strong analytical and problem-solving skills, with a focus on risk management and continuous improvement. Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at /careers/benefits-perks. About us: Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: United States (US) Massachusetts (US-MA) Westborough Manufacturing & Repair
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