Executive Director Clinical Quality Assurance (CQA), Global

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

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 pharmaceutical 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 i