Position Summary:
The Sr. Specialist, Quality Assurance is a key role within Biomea Fusion’s Quality team which assists oversight of core capabilities related to: the review of executed batch documentation, test results, labeling materials, shipping and distribution records and Biomea’s Quality Management System. The incumbent will routinely interact with cross‑functional peers across Biomea to ensure alignment in practices so that capabilities under his/her scope meet the needs of the business. This role is based in Redwood City, CA and required to be onsite 3 days per week.
Essential Responsibilities:
• Work with CMC/Technical Operations and Development Teams to review and approve manufacturing and related documentation, including completed batch records, testing/release records, stability protocols, and other documentation generated by contract manufacturers in support of GMP operations.
• Support GMP external compliance audits of vendors
• Responsibilities will include oversight of necessary Investigations
• Manage controlled documents
• Ensures documentation suitability against regulatory standards
• Reviews regulatory submissions to confirm compliance with approved practices and procedures
• Assist with the implementation of an electronic document management system
• Ensure corporate compliance with Quality System Policy
• Assist with internal compliance inspections
• Support the external GMP audits of contract vendors and organizations
• Revise internal Standard Operating Procedures and Policies
• Support regulatory inspections and responses/actions for assigned areas.
• Support management review process through development and generation of quality system and trending.
• Execute other functional or company-wide projects or initiatives as assigned.
Education and Experience Requirements:
• Bachelor’s degree in life sciences, engineering, or other related discipline and relevant work experience
• 3-5 years of experience in quality or manufacturing oversight roles in the pharmaceutical, biopharmaceutical, or medical device industries in a global clinical and/or commercial environment
• Experience in establishing processes and associated electronic systems
• Working knowledge of global GxP regulations, requirements, and guidelines (e.g., US, EU, and ICH)
• Strong leadership and influencing skills with proven ability to lead cross-functional teams
• Excellent verbal and written communication skills; highly diplomatic
• 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.
Industry:
• Biotechnology
Employment Type:
• Full-time
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.
The expected salary range for fully qualified candidates applying for this role is $125,000 to $145,000. An individual’s position within the range is based on multiple factors, including education, relevant experience, and length of industry experience; these factors will influence the actual salary offered. In addition to a competitive compensation package, Biomea Fusion, Inc, offers a comprehensive benefits package
