ABL is looking for a Sr. Quality Assurance Manager to provide a leadership role and to support Quality Assurance activities in support for internal Contract Manufacturing activities (Phase I/II).
This position provides guidance necessary to maintain and improve the cGMP compliance at ABL in accordance with FDA, ICH, and other applicable 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.
• Provide Quality Assurance guidance to Quality Assurance 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.
• Ensure 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 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.
• 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 and other applicable regulation requirements.
• Experienced and knowledgeable with quality assurance requirements for 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
• Must be able to lift up to 25 lbs with or without reasonable accommodations