Manager, Quality Assurance Operations – Flexion Therapeutics – Burlington, MA, USA
Flexion Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA), a type of degenerative arthritis. The company is currently advancing a drug candidate that has the potential to provide rapid, powerful, and durable pain relief compared with existing therapies.
Our lead product candidate, Zilretta™ (also known as FX006) is a sustained-release, intra-articular, non-opioid investigational treatment in late-stage development for patients with moderate to severe OA pain.
The Role:
We are looking for a Manager, Quality Assurance Operations to join our growing team. In this role, you will have the opportunity to provide quality oversight and direction to third parties for all packaging, storage, and distribution activities for clinical and commercial products to ensure compliance with current Good Manufacturing Practices (cGMPs).
Responsibilities:
The Manager, Quality Assurance Operations will be responsible for the following activities:
- Contract Manufacturing Organization (CMO) Oversight
- Perform batch record review and release of finished product
- Review and approve CMO documentation, including but not limited to master batch records, artwork, specifications, SOPs, validation protocols and reports.
- Manage (review, track, and close-out) in collaboration with CMOs deviations, investigations, change controls, complaints, and corrective and preventative actions.
- Assist with FDA and other regulatory agency inspections as needed.
- Supply Chain Management and Distribution Oversight
- Partners with Supply Chain to identify any product specific quality and compliance risks and develops mitigation plans based on a risk based approach.
- Review and approve shipping qualification protocols and reports.
- Assess temperature excursions and provide corresponding quality decision on the product.
- Supports the implementation of at Electronic Product Code Information Service (EPCIS) Solution at Flexion for serialization.
- Supports the implementation of new ERP modules including Inventory Control.
- Vendor Management
- Plan, conduct and document periodic cGMP audits of GMP vendors.
- Develop and maintain quality agreements and quality questionnaires.
- Lead vendor performance reviews.
Requirements:
- Experience working with commercial packaging/labeling vendors is required.
- Demonstrated knowledge of Quality Systems and cGMP within a FDA-regulated environment.
- Strong knowledge of Cold Chain activities.
- Thorough knowledge of cGMPs/GDPs and global regulatory requirements.
- Working knowledge of 21 CFR Part 11 and computerized system regulations.
- Bachelor’s degree is in Chemistry, Biology, or Life Sciences is
- Minimum of 6 years direct QA experience in a cGMP environment.
- Ability to travel.
- Auditing experience is required.
- Excellent organizational and time management skills with a high level of attention to detail.
- Excellent oral and written communication skills for effectively interfacing with internal and external organizations.
Candidate Profile:
- Enjoys working in a fast-paced, small-company environment.
- High levels of organization, attention to detail, and accuracy
- Proactively identifies issues and identifies solutions.
- Acts with urgency and passion. Enjoys helping others.
- Exceptional interpersonal skills, with a focus on rapport-building, listening and questioning skills.
- Ability to execute assignments within established timeframes and quality standards, while responding to immediate needs.
