About the role
Associate Director Quality Assurance role based on the published job description. Key responsibilities and requirements were extracted directly from the posting for quick review.
BiotechOnsiteQuality
Key Responsibilities
- Responsible for providing oversight and leadership for Quality on-the-floor and functional area support, the Assoc Dir Quality Assurance will support all direct manufacturing.
- The role involves leading and guiding a team of FTEs, trainees and a number of CW Staff.
- The areas of responsibility include projects, quality oversight of day-to-day activities, deviations, CAPAs and Change Controls and managing Subject Matter Experts responsible for key Quality Management Systems such as Deviations/CAPAs, Change Controls, Quality Risk Management and Document Management System.
- Main Responsibilities: Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
- Support routine GMP Oversight activities (e.g.
- SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics Ensure required Quality resources are available to support commercial operations.
Requirements
- Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance 10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
- Direct experience with bulk manufacturing of biopharmaceuticals preferred.
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff Your selection for this role will be subject to fulfilling the medical requirements: of this job scope.
- If so, you will be informed of the medical check(s) that you may need to undergo.
- All medical related expenses incurred from this medical check shall be borne by the company.
- Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.