Head of QA Operations

Head of QA Operations

Requisition ID: 125517BR

When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Lexington Massachusetts

How will you make an impact?

This position reports to the Quality Site Head and is responsible for providing management and leadership to Quality Assurance on the Floor and Lot Disposition group of quality professionals. The role includes final disposition decision for drug substance and drug product for viral vector products. This may include QA assessment of change controls, deviations, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the QA decision maker. In addition to managing the QA staff, this role will manage and facilitate quality projects and risk assessments for the site by working closely with multifaceted teams such as Manufacturing, MSAT, QC, Engineering and Facilities.

What will you do?

• Manage QA staff for Quality Assurance on the Floor and Lot Disposition
• Perform lot disposition decisions
• Organize and prioritize QA group tasks
• Facilitate risk assessments and implementation of best practices
• Mange multi-quality projects for operations and site
• Support key decisions in quality operations
• Drive timely decisions and facilitates active communication and information between department management
• Demonstrate substantial knowledge of industry best practices and trends
• Other tasks as assigned by management
• Delegate for Quality Site Head
• Work effectively with people, including good investigation, problem solving and organization skills

How will you get here?

Education

BS/MS in Biology or related science discipline and 15 + years of experience in a cGMP manufacturing or QA Operations environment, with strong knowledge of GMP operations and regulations. Experience in cell or gene therapy, project management, risk assessments, QA operations and lot disposition. MBA or PMP certification a bonus.

Experience

• Proficient in cGMPs applicability and decision making
• Experience in batch record review and manufacturing operations
• Skilled in lot disposition decision making
• Demonstrated ability in decision making and providing direction to operators on next steps
• Excellent written and verbal communication skills
• Management of quality operations team and working with other QA departments
• Capable to interface with multiple departments and work in cross functional teams
• Must have attention to detail and good investigation, problem solving and organizational skills
• Ability to work effectively with people and communicate challenging information and obtain positive results
• Works well and facilitates positive interdepartmental interactions with a diverse group of people. Voluntarily communicates needs and suggestions clearly and effectively. Listens and is attentive to others
• Capable of being flexible as required tasks change and maintain productivity
• Keeps project leads and team members informed of the status of assigned work
• Must be a strong, dependable team player
• Ability to work with Microsoft Office applications
• Resolve differing perspectives with effective negotiation skills
• Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects/tasks to completion

Knowledge, Skills, Abilities

• Skilled in use of Microsoft Outlook, Powerpoint, Word, TrackWise, LIMS, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
• This position requires the ability to work in a fast-paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
• Able to review and provide details to ensure accurate written records, manage time effectively and be organized
• Application of Risk Assessment Tools
• Ability to manage multiple projects at one time

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.