The Manager/Senior Manager, Quality supports quality efforts across GxP functions, providing cross-GxP (GCP, GLP and PV) quality advice and expertise, overseeing audit programs, managing and executing audits. Additionally, this role will play an integral role in managing internal compliance programs such as deviation management, CAPA management and investigations.
- Administer the GxP vendor audit program, including on-going risk assessment and audit prioritization
- Direct contract auditors to address audit program needs
- Manage the qualification program for GxP vendors
- Provide support clinical study programs with GCP advice on an ad-hoc basis
- Conduct GxP audits both remotely and in-person
- Provide QA support of validation of GxP systems
- Develop and administer process for managing / processing of product complaints, deviations and CAPAs
- Support the development of Inspection Readiness processes across GxPs
Education and Experience Requirements:
- BS/BSc degree (Masters or greater preferred) or equivalent experience
- Prior experience managing and executing vendor, internal process, and/or clinical site audit programs in the biopharma industry
- Experience managing deviations and/or CAPA processes
- Experience authoring, reviewing, and managing controlled documents
- Experience with technologies such as EDC, IRT, CTMS, ePRO
- Knowledge of computer system validation (i.e. 21 CFR Part 11)
- Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.