Quality Assurance Manager - Cambridge
- Job type: Permanent
- Salary: High
- Location: Cambridge
- Reference: RE-32496435
Responsible for oversight of CMO's. Responsible for the oversight and execution, from a quality perspective, of chemistry, manufacturing and control (CMC) related activities for assigned small molecule drug candidates through all stages of clinical development to global commercialization. The role will involve interaction with the internal project team (and sub-team) members and external suppliers. The Candidate is expected to exhibit strong organizational leadership and values.
Oversee quality aspects of pharmaceutical development in an outsourcing environment, for drug substance (DS), drug product (DP) and clinical trial material (CTM), including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, labeling, product release, distribution and associated stability programs, for assigned drug programs.
Perform quality assurance activities (such as validation protocol/report review and approval, specification review and approval, batch record review and release, etc.) to ensure timely delivery of DS, DP and finished (packaged and labeled) product to support the clinical development plan, as well as the commercial sales plan as appropriate.
Review label text and maintain label specimens.
Maintain quality systems in relation to assigned drug programs and suppliers e.g. change control, deviations, complaints and other tracking lists.
Oversee supplier quality management activities for assigned suppliers. Oversight to include confirmation of compliance, inspection readiness and appropriate corrective action plans, as required.
Ensure company and industry standards for quality assurance and compliance to regulatory requirements are applied to assigned drug programs and suppliers.
Ensure supporting product, supplier and quality systems documentation is maintained in accordance with company and industry standards.
Review content and documents in support of regulatory submissions for investigational products, market applications and periodic updates.
Perform assigned internal audits.
Participate on cross-functional teams, as needed.
Report to supervisor on project progress, issues and problem solving.
Draft assigned standard operating procedures and work instructions.
Assist with computer validation activities, as assigned.
Support other objectives, as assigned.
Skills & Requirements
* Strong technical, analytical and writing skills to identify and solve problems and document them appropriately.
* Ability to exercise independent judgment in making decisions to assure product quality.
* Working knowledge of drug development process, FDA/EMA/ICH guidelines and GMPs, especially as applied to small molecule development, particularly oral dosage forms.
* Working knowledge of validation as applied to pharmaceutical manufacturing, testing and equipment.
* Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World.
* Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding fast-paced environment.
* Excellent oral and written communication skills for effectively interfacing with other departments within the company, suppliers, and other contractors.
* Demonstrated audit conduct and management experience is desired.
* Education and Experience
* At least five years' experience in a quality role within a pharmaceutical development setting required. A degree in Pharmacy/Pharmaceutical Sciences, Chemistry, Analytical Chemistry or related scientific discipline is desirable.
* Expertise in the areas of CMC, Quality and Regulatory.This is an office-based position with approximately 10% travel.