Senior Quality Assurance (QA) Manager
Location: Bristol, PA
The Senior Quality Assurance Manager will be responsible for the development, implementation and oversight of Quality Compliance to support CGMP manufacture of API for client’s Phase I-III clinical materials. This position is deputy to the Director of Quality Assurance for Abzena (Bristol), supports the management of the overall Quality Assurance/Compliance program, and may supervise junior Quality personnel as required. The position requires the ability to operate with a high level of independence and ability to make sound quality and compliance related decisions in a fast-paced, dynamic environment.
- Ensure GMP manufacturing and testing activities are meeting compliance requirements with respect to internal procedures as well as FDA, EU, ICH, and other regulatory requirements.
- Independently host and/or support client site visits and audits, as required, with the ability to coordinate and manage all aspects of an audit, including responding to observations.
- Manage internal audit program for cGMP operations and perform external audits of suppliers and contract testing laboratories, as necessary,
- Review and approve qualification/validation/requalification of manufacturing facilities and equipment used in GMP production.
- Review and approve analytical method qualification/validation protocols and reports to ICH and FDA requirements and standards.
- Provide quality input for failure analysis, complex problem solving, and risk assessment and mitigation activities related to the qualification and validation of the GMP facility and equipment in relation to ICH standards.
- Oversee and manage deviation, change control, and CAPA programs with attention to compliance and completion within specified timeframes. Partner with other departments to identify solutions and improvements to existing systems.
- Proactively resolve moderately complex production deviations, including Quality Control Out-of-Specification and Equipment Out-of-Tolerance investigations, or any other quality events.
- Review and approve of reference standard qualification and stability reports.
- Author and review SOPs, protocols, reports and Validation Master Plans for GMP facility, equipment and instruments. Review and approve final reports.
- Provides direct supervision, coaching and training to varying levels of Quality staff.
- Assists the Director in Department level initiatives, as required.
- Serves as a primary point of contact for client in GMP/QA related activities.
- Represents QA in cross-functional teams.
- Establishes department goals and priorities and assignment of activities to Quality staff.
- Ability to execute as a valuable resourceful team player with a high level of independency.
- Operate as the lead Compliance point person on manufacturing and laboratory related topics.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards established by regulations and Abzena’s policies, procedures and mission.
- Communicates effectively with colleagues, clients and staff.
- Travels as needed.
- Bachelor’s degree, or higher, in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.) with a minimum of 15 years of experience in the pharmaceutical industry.
- Broad knowledge of drug development (research, toxicology, through Phase III)
- Strong understanding of quality compliance in relation to GMP manufacturing and laboratory processes – Essential requirement.
- At least eight (10+) years of Quality Assurance-related experience in a current Good Manufacturing Practices (cGMP) environment.
- Strong knowledge and understanding of FDA, EU, and ICH compliance requirements and guidelines related to CGMP operations.
- Experience working within a service or contract manufacturing organization (CMO) strongly desired.
- Experience with GMP QC testing and/or review of GMP analytical and/or bioanalytical laboratory data and OOS investigations preferred.
- Experience with IQ/OQ/PQ and facility validation a plus.
- Experience in aseptic processing experience with respect to drug product formulation, filling, and finishing a plus.
- Ability to assess, review, and approve laboratory and manufacturing investigations.
- Skill utilizing electronic quality management systems – a plus, not required.
- Ability to effectively interact with vendors, clients, inspectors and regulatory authorities.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of independence and productivity – Essential requirement.
- Ability to perform successfully in an intense work environment
- Ability to supervise and manage employees.