Position Summary:

Manager, GCP Quality supports quality efforts across all GxP functions, with a focus on GCP areas. The Manager, GCP Quality provides quality support, administers GCP QMS activities, participates in inspection readiness and produces departmental metrics/reporting. In addition, this role assists with GCP-related audits. This role will be onsite in Redwood City, CA.

Essential Responsibilities:

• Administer the GxP vendor audit program.
• Identify and facilitate documentation needs for contract/outsourced auditors to perform GCP audits on Biomea’s behalf.
• Manage the qualification program records for GxP vendors, including organization of documentation and verification of vendor’s GxP status.
• Provide support for clinical study programs with GCP compliance, as needed.
• Participate in GCP audits both remotely and in-person.
• Provide support for the validation of GxP computer systems.
• Processing documents for supporting deviations and CAPAs.
• Gather and produce departmental QA metrics and reports.
• Assist in conduct of investigations of scientific fraud and misconduct.
• Work with stakeholder clinical study functions in BIMO readiness activities
• Assist and develop GCP Inspection Readiness processes and materials.
• Assist hosting GCP regulatory inspections.
• Provide support for Biomea quality-related initiatives and short-term projects across GCP functions.
• Assist in document management and training functions across GxP areas.

Education and Experience Requirements:

• BS/BSc degree (MS or greater preferred) in relevant field
• 8 years with BS/BSc (or 6 years with MS) of progressive background in the biopharma industry with direct GCP quality assurance experience.
• Experience authoring, reviewing, and managing controlled documents in the biopharma context.
• Experience administering deviation and/or CAPA processes.
• Experience managing and/or conducting vendor, internal process, and/or clinical site audit programs in the biopharma industry preferred.
• Audit certification preferred.
• Experience with technologies such as EDC, IRT, CTMS, ePRO preferred.
• Knowledge of computer system validation (i.e. 21 CFR Part 11) preferred.
• Experience with Veeva Quality Docs and Veeva Training preferred.
• Excellent verbal and written communication skills, and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
• Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
• Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
• Collaborative, team-oriented mindset
• Travel required between 20-30%.
• Self-motivated, detail-oriented with exceptional organizational, leadership and interpersonal skills.

Industry:

• Biotechnology

Employment Type:

• Full-time (on-site)

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.