Quality Assurance Manager
Exciting opportunity for experienced leader to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections.
The Quality Assurance (QA) Manager will manage the day-to-day operations of the QA Team, including direction of staff. The QA Manager will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Control, Regulatory Affairs, and Supply Chain to ensure QA deliverables are met. Assist in the design of phase-appropriate QA systems including implementation and continuous improvement to ensure patient safety and data integrity. Manage product release. Provides leadership, direction, and mentorship across all levels of the organization to assure QA strategies are known and implemented. Acts as a backup point of contact (POC) on QA matters, internally and externally.
- Responsible for day-to-day operations of the QA team.
- Lead and direct product release activities (GMP and non-GMP). Includes provision of certificate of analysis (CoA) content and regulatory filing content.
- Works as QA POC to provide technical expertise on deviations, OOS/OOT investigations. Acts as QA Lead on QA related deviations and investigations.
- Ensures QA work is conducted following cGMP requirements and APT procedures.
- Quickly identify and resolve gaps and provide expertise during complex troubleshooting.
- Write technical documents such as reports, change controls, investigations, and SOPs. Includes reviewing and approving these document types.
- Hire, develop, and retain QA personnel (including temporary, contract, and/or consultant staff) to maintain a high-performing credible team.
- Communicate effectively and cross-functionally.
- Participate in and lead audits as needed (internal, regulatory, and/or partner).
- Skilled in development and implementation of phase-appropriate quality systems
- Ability to solve complex technical issues and drive to closure
- Skill in building and maintaining cross functional relationships across areas
- Ability to manage multiple priorities with a sense of urgency to meet timelines
- Adaptable to change
- Excellent communication skills; verbal and written; with various levels of internal and external organizations
- Bachelor of Science degree / equivalent in life sciences or related field
- 5+ years of experience in the pharmaceutical and biotechnology industries
- 3+ years supervisory experience in industry
- Strong knowledge of FDA and ex-US regulations in development through commercial
- Experience in microbiology and virology preferred
- Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint)
- Experience with government contracting desired
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to HR@aphage.com
Job ID: 21.027