Sr. Quality Assurance Manager
The Sr. Quality Assurance Manager is responsible for providing leadership role and support Quality Assurance activities in support for internal process development, Contract Manufacturing activities (Phase I/II), and Contracted-out cGMP services. This position provides guidance necessary to maintain and improve the cGMP compliance at ABL in accordance with FDA, EU, ICH, WHO and DAIDS guidelines. This position will also establish and review/approve key quality system related documents and ensure continuous compliance at ABL.
The main responsibilities will include but are not limited to:
- Manage & provide Quality Assurance support to fast pace multiple cGMP projects and Supplier Quality.
- Provide Quality Assurance guidance to Quality Assurance and Document Control personnel.
- Provide Quality Assurance updates to the clients.
- Coordinate and approve product release to the clients.
- Provide guidance and quality assurance support to cGMP personnel for the compliance.
- Manage and coordinate review and approve of Quality related documents for cGMP activities.
- Ensure ABL procedures and policies are in compliance with applicable FDA and International guidelines.
- Ensure raw materials, intermediate products and final products are appropriately released as per requirements.
- Review and approve equipment qualification, maintenance and calibration program are effective.
- Review and approve GMP analytical and bioanalytical data is reviewed for compliance.
- Ensure analytical methods are qualified and/or validated appropriately in accordance with ICH guidelines.
- Perform and support audits for GMP activities to evaluate the compliance with the procedures and practices.
- Manage and coordinate issuance of quality documents such as batch records, test methods, product labels and other documents for cGMP activities.
- Review completed batch records, Environmental monitoring data, laboratory records and other ancillary data for product release.
- Review and provide feedback comments on investigation reports, protocols/reports/specifications and other quality documents.
- Provide ongoing assessment, ideas and assistance in enhancing quality system at ABL.
- Responsible for continuous improvements to the ABL Facility and Quality Systems.
- Provides guidance and training to ABL staff regarding GMP compliance.
- Reports quality deficiencies to the Department Heads.
- Other duties as assigned.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
- BS in science or related scientific field with minimum of 7 to 10 years in GMP compliance.
- Possess In-depth experience and knowledge of cGMP, ICH, EU and FDA regulations requirements.
- Experienced and knowledgeable with quality assurance requirements for preclinical and clinical drug development program biologics manufacturing and product release.
- Project management skills such as developing, overseeing and following timelines as well as tracking quality requirements and deliverables will be required. Intermediate computer skills using MS Office (Word, Excel) preferred.
- Proven Supervisory, Leadership and Management skills.
- Possess excellent interpersonal skills, both communication and written. Must be able to articulate and communicate effectively with all echelons of Management and staff.
- Task & Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task