Manager, Qa

Job Description

When you’re 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
Work Location: St. Louis, MO (on-site)

Group: Pharma Services Group

Division: Drug Substance Division

How will you make an impact?

The QA Compliance Manager will have responsibility over the Quality Compliance Department. This includes, but is not limited to, ensuring site compliance with FDA, EMA and other cGMP regulations, overseeing programs including Site Internal Audits, Client Audit Management, Inspection Readiness, Corporate Gap Assessments, and Metrics. This individual provides leadership to assigned staff by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

What will you do?

• Oversee, manage, and ensure the successful day-to-day operations of Quality Compliance department for the company.
• Manages site internal and client audit programs, including planning, execution, response and remediation activities.
• Responsible for site inspection readiness program and successful execution of regulatory inspections, including routine GMP and Pre-Approval / Pre-License inspections.
• Ensures favorable outcome of both client audits and regulatory inspections of the facility.
• Provide support for client cGMP regulatory submissions, as necessary.
• Reviews and approves department standard operating procedures.
• Assists with department functions, including, but not limited to, conducting internal audits, facilitation or support of client audits, and regulatory inspections.
• Oversees daily activity for the group to ensure appropriate quality, to ensure commitments are met and maintenance of schedules.
• Provide support for site safety initiatives.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.
• As part of the role, you will represent the company at regulatory inspections, respond to questions, coordinate responses and corrective actions as appropriate.
• Oversees daily activity for the group to ensure appropriate quality and output and maintenance of schedules. May assist in performing tasks of the group.
• Sets objectives and tasks for staff and regularly review staff progress in meeting objectives.
• Effectively communicates with peers, Manufacturing, Process Development, Procurement and Quality Control staff, to resolve technical issues and direct activities.
• Provides support to site safety initiatives.

How will you get here?

Education

• Bachelor’s Degree in Life Sciences, Biotechnology, Engineering, or equivalent.

Experience

• 8+ years of experience within a GMP Environment
• 5+ years of experience within Quality Assurance or Quality Compliance preferred
• 3+ years in a leadership role is preferred

Knowledge, Skills and Abilities

• Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
• In-depth knowledge of FDA, EMA, and other applicable regulatory requirements.
• Proficient with computer (MS Office), and internet skills. Proficient in use and understanding of controlled documentation and data systems.
• Excels in cross functional team environments.
• Well organized and able to work independently with minimal supervision.
• Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence.
• Knowledge of pre-license / pre-approval inspection readiness and regulatory submissions is preferred.
• Experience with regulatory inspections.
• Excels in cross functional team environments.
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• Leadership Skills: Proven ability to influence others and lead significant change.
• Strong communication and presentation skills, both written and verbal.

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 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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