Head Of Quality Control

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading, and groundbreaking, Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

The Head of Quality Control provides leadership and scientific and technical expertise for all QC activities at the Lexington, Massachusetts site.

What will you do?

• Leads team of managers and supervisors and professionals within Quality Control. Manage and leads employees within the department. Assigns work, mentors, and takes vital disciplinary actions.
• Develops appropriate operating and capital expense budgets for Quality Control.
• Serves as primary QC contact for regulatory inspections and client audits.
• Provide oversight of method qualification and validation from Assay Development and Analytics and/or clients.
• Establish and maintain stability programs for clients.
• Support establishment and/or enhancement of QC and operational metrics.
• Sponsor, lead, and/or support establishment of electronic LIMS systems for site.
• Analyzes regulatory authorities’ programs, mentorship documents and activities in areas relevant to testing of biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
• Evaluates the functional strengths and developmental areas in the QC organization and focuses on continuous improvement.

How will you get here?

Education:

• Minimum required education: Bachelor’s Degree in a scientific/technical field
• Master’s degree preferred

​Experience:

• 10+ years of experience in a quality position
• 5+ years in a leadership role within the biologics and/or pharmaceutical industry.
• Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
• Experience with performing root cause analysis and writing Deviations and Lab Investigations required.
• Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.

Knowledge, Skills, Abilities:

• Excellent social skills.
• Ability to multitask, strategically and tactically.
• Confirmed knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Ability to write reports, business correspondence and procedure manuals.
• Strong communication skills; ability to prioritize and manage through sophisticated processes/projects.
• Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
• Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems.
• Ability to take care of abstract and concrete variables in situations where only limited standardization exists.
• Ability to apply various standard programs for data entry and word processing.
• Ability to use software and customized programs to meet business needs.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.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.

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