Manager, Quality Control - Biologics Analytical Operations

Job Description

Essential Duties and Job Functions:

• Executes the Quality Control product quality function, ensuring processes provide high quality analytical support for internal and external production, product monitoring and trending, and collaboration with process and analytical development while ensuring compliance of protocols, GMP’s, and safety regulations.
• Owns and directs efforts in support of Quality Systems records, deviations, CAPAs, and change controls.
• Leads and represents QC requirements on multiple projects.
• Works with Regulatory & Quality Assurance to ensure that all procedures and applicable regulatory requirements are followed and properly documented.
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.
• Analyze process, lead improvement activities, and empower staff to create a lean culture in the laboratory.
• Will work on more complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations – typically high impact issues that have implications across functions.
• Supports and/or coordinates internal and external regulatory audits as required.

Required Education, Experience and Skills:

• Bachelor’s or master’s degree in the analytical chemistry, biochemistry, microbiology, pharmacology or a related discipline from an accredited university.
• Bachelor’s degree will possess 7+ years of relevant biotech/pharmaceutical professional experience.
• Master’s degree will possess 5+ relevant biotech/pharmaceutical professional experience.
• Excellent communication skills (both verbal and technical) and interpersonal skills are required.
• Demonstrated people management skills required
• Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality Control and outside of the function.
• Demonstrated ability in integrating varied concepts and data to develop relevant solutions
• Demonstrated ability to create an energizing team environment
• Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
• In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• In-depth knowledge of QC principles, concepts, industry practices, and standards
• Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
• Knowledge and experience in commercial Quality Control in a highly regulated manufacturing environments is preferred