Quality Assurance Manager Jobs

Responsibilities:

• Review and/or approve technical documents including deviations, CAPAs and Change Controls.

• Manage quality tasks/responsibilities related to Change Controls (Process and Analytical) associated with the Tech Transfer.

• Reviewing Master and executed batch records for completeness and compliance to all associated source documents and regulatory filings and executing the batch disposition process

• Support GMP and PPQ readiness including review of source documents, Validation protocols and reports, Master Batch Records, Change Controls and Deviations.

• Participate in Quality Risk Management activities associated with the Tech Transfer project and External Entity.

Qualifications:

• Bachelor’s degree or higher in a scientific or technical discipline

Required Experience and Skills:

• Minimum of 7 years’ experience in the pharmaceutical industry with a thorough knowledge and broad experience of Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.

• Must have hands-on experience working in IT - Quality Management Systems (SAP, Trackwise, etc.).

• Biological Drug Substance experience, including experience in Process and Analytical Tech Transfer

• Experience with biologic and/or vaccine Quality Assurance, Quality Control, and manufacturing processes.

• Must have strong interpersonal, communication, coaching, motivation, negotiation, multitasking, and persuasion skills to build strong relationships.

Preferred Experience and Skills:

• Excellent analytical and computer skills, including experience with Microsoft team

• The ability to navigate in a complex environment with the ability to make ambiguous situations clear to stakeholders (e.g., process mapping, PowerPoint).

• Strong collaboration, influencing skills along with Six Sigma / MPS experience. Ability to work independently and interact with all levels of the organization.