Associate Director, Quality Control - GMP
Associate Director / Director, Quality Control
Location: Bedford, MA
Job Code: QQCD0020-18
The HMI Director/Associate Director of Quality Control (QC) is responsible for development, implementation and maintenance of quality control systems and activities in accordance with US and international regulatory requirements. The candidate will have the opportunity to start-up the laboratories that will support a new clinical phase I/II GMP manufacturing facility. The leader will also recruit, manage and develop the QC team that will perform sample management, raw material and product specifications, raw material testing, in-process, drug substance and drug product release testing, stability testing and trending and environmental monitoring. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of our patients.
Essential Functions and Duties
- Build, develop and manage the QC organization including staff, departmental goals and corporate goals/culture
- Serve as QC lead for design, procurement, analytical instrument qualification, tech transfer and method qualification for start-up of a new clinical drug substance and drug product GMP Manufacturing facility
- Develop, implement and maintain QC system and procedures, such as sample management, release testing, laboratory investigations and trending
- Oversee operations of the internal QC lab, external testing labs and stability program to ensure compliance with internal procedures and regulatory requirements.
- Support development and management of QC specifications for in-process, release and stability programs
- Prepare and review documentation required for regulatory submissions
- Lead functional discussions during inspections conducted by external regulatory agencies and business partners
- Partner with cross-functional teams to ensure successful delivery of key milestones
Skills and Experience
- Bachelor’s degree in chemistry, biology, microbiology or equivalent. Advanced or doctorate degree in a scientific discipline preferred.
- Minimum 15 years of experience in the pharmaceutical/biotech industry with a minimum of 10 years’ experience leading teams in a FDA-regulated environment.
- Prior experience in method qualification, method transfers, validation, quality control execution and laboratory investigations.
- Comprehensive knowledge of quality principles and GMP, ICH and GLP regulations.
- Ability to develop a clear functional strategy, prioritize activities, coach & guide team members effectively, and to deal with multiple parallel competing activities is a must.
- Strong interpersonal skills; the ability to interact effectively with all levels within the organization, external third parties, and regulatory authorities
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Self-driven, independently motivated, data driven, and excellent problem-solving ability.
Interested candidates should forward a cover letter and resume/CV to email@example.com.
Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.