Senior Quality Audits & Compliance Lead
About The Position
The Senior Clinical QA Lead serves as Audit Lead for Biopharma Qualification Audits and select Partner Routine Audits. The role is responsible for successful audit execution, including preparation activities such as facilitating pre-audit calls, leading internal audit preparation meetings, and conducting the audit. During audits, the Lead serves as a point of contact for internal stakeholders and ensures audit objectives are met. The position collaborates with groups throughout the organization to support compliance with regulatory requirements and a range of projects and initiatives. It contributes to Quality Assurance activities across multiple quality system requirements, including CLIA/CAP, GCP, ISO, and FDA-regulated environments. Domestic travel of up to 10% is required. The role also supports other QA duties as assigned and complies with FMI attendance policies.
Requirements
- Bachelor’s degree in a science or engineering discipline and 5 or more years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials; or a master’s degree in a science or engineering discipline and 3 or more years of experience.
Nice To Haves
- Experience or familiarity with medical devices.
- Knowledge of Good Clinical Practice (GCP).
- Demonstrated ability to maintain accurate audit records.
- Knowledge of Microsoft Office applications, such as Word, Excel, and PowerPoint.
- Knowledge of root cause analysis and corrective and preventative action.
- Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
- Ability to communicate effectively verbally and in writing within the team and with other functional teams.
- Ability to cooperate and collaborate effectively with a team.
- Highly detail-oriented.
- Excellent time-management skills and ability to deliver requested tasks on time.
- Understanding of HIPAA and the importance of patient data privacy.
- Commitment to reflect FMI’s values: Integrity, Courage, and Passion.
Responsibilities
- Lead Biopharma Qualification and Routine Audits, as requested.
- Support external audits performed by regulatory and inspection agencies.
- Facilitate audit and inspection readiness training and activities.
- Track and manage pre-audit deliverables to ensure timely fulfillment.
- Support communication of audit observations and recommendations.
- Support preparation of audit responses.
- Support compilation of audit metrics.
- Assist with internal GCP activities, such as internal audits.
- Contribute to development of controlled documentation, as needed.
- Travel domestically up to 10% of the time.
- Support other QA duties as assigned.
- Comply with FMI's attendance policies.
Benefits
- Benefits through Foundation Medicine.
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
