Role Summary:
The Sr. Manager Clinical QA will support the implementation and management of the Quality Assurance strategy across all studies. They will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to GCP in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of patients. This role executes and manages Clinical QA-GCP audits and provides GCP guidance and advice across the company, as well as authoring and reviewing applicable Quality sections of regulatory submissions. The Sr.
Manager Clinical QA is accountable for GCP oversight, and for assuring the compliance of studies with SOPs, policies, and all applicable global regulations and guidelines (Eg. FDA, EMA, ICH etc). The Sr. Manager Clinical QA will be highly cross functional interacting with internal and external partners in the areas of clinical operations, QA and regulatory. This role will develop and implement procedures and SOPs as well as supporting the initiation of a fit for purposes QMS in line with GCP best practices.
Essential Duties and Responsibilities
:
- Define, implement, and optimize risk-based quality management plans for clinical assets.
- Proactively identify potential program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful submissions.
- Leads or assists in authoring Non-clinical and Clinical Standard Operating Procedures (SOP's).
- Provide global GCP guidance for cross-functional development teams inclusive of the review of critical documents (e.g., study protocols, investigator’s brochure, periodic reports).
- Assist in constructing annual GLP and GCP training.
- Support issue management and corrective/preventive action management activities both internally and with external service providers.
- Guide proactive inspection readiness activities globally; Support questions from regulators, review boards, ethics committees, development partners, etc.
- Manage clinical vendors, assuring appropriate oversight and assessment; maintain the central repository of vendors, current status of approval/qualification, and audit frequency.
- Design and implement risk-based audit plans which may include but are not limited to clinical investigator site audits and vendor audits; Conduct and/or oversee audits in accordance with audits plans.
- Oversee and ensure compliance with quality assurance and regulatory procedures and best work practice.
- Keep abreast of new FDA / EMA regulatory requirements, as well as those from other key International regulatory authorities to enable quality excellence.
- Interpret and apply applicable Health Authority regulations and guidance.
- Draft, implement, and enhance written procedures to support the clinical QMS and provide administrative support for the document management system within Clinical QA.
- Steer, review, deliver, and confirm role-based training plans and provide administrative support for the training program.
- Drive efforts to identify and implement new technologies to optimize quality and documentation of compliance (e.g., electronic QMS, electronic trial master file, clinical trial management system, safety tools, learning management system).
- Travel up to 15% time, based upon program needs
Education and/or Work Experience Requirements:
- BS/BA or equivalent in life sciences or health-related field
- A minimum of 7+ years of GCP quality experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
- Experience maintaining and optimizing quality management systems; Desire to employ quality by design principles to optimize quality
- Experience management in issue/risk lifecycle (e.g., identify, evaluate, escalate, manage, close, effectiveness check)
- Experience planning and conducting GCP audits
- Experience authoring and completing quality review of regulatory documents.
- Experience drafting, reviewing, implementing, and optimizing operating procedures and associated training plans.
- Understanding of global regulatory inspection process.
- Ability to manage multiple projects at one time.
- Demonstratable ability to operate independently in an entrepreneurial environment.
- Solution focused with a compliance mindset and a pragmatic approach.
- Excellent interpersonal skills and problem solving/decision making skills.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Fore Bio provides equal employment opportunities (EEO) to all employees and applicant for employment without regard to religion, race, creed, color, sex orientation, national origin, age, marital status or any other characteristic protected by applicable federal, state, or local law.
