1+ months

Manager, QA - Plant Quality

Florida, NY 12010
Location :
US - Florida - Gainesville
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 drug supply chain or making sure our medicines are safe, efficacious, and of impeccable quality. Your work will have real-world impact, and you’ll be supported in achieving your career goals.


Alachua, FL

How will you make an impact?

The QA Manager of Plant Quality’s primary responsibility is to ensure quality and compliance at our Alachua, FL site with respect to relevant Standard Operating Procedures, applicable Regulatory requirements (FDA, EU, ICH), and current industry standards and practices. The Manager will lead a team of professional QA personnel to support internal and external customers in matters of product quality. The Manager is expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency. The position is client facing and is called upon to represent QA in client meetings, internal and external regulatory audits, and updates.

What will you do?

* Manage the plant quality teams, both on-the-floor GMP QA and technical services and provide routine updates and metrics on outstanding commitments

* Provide 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.

* Ensure the QA – GMP Quality group successfully ensures the quality of all GMP manufacturing activities, successfully performs batch review and disposition activities to meet specified timelines, and ensure the batch disposition process is robust and continually seek ways to improve the disposition process.

* Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements

* Provide monthly metrics related to batch review activities

* Apply risk management principles and provide input to risk-based decisions in the areas of qualification and validation.

* Provide guidance for qualification and validation activities based on experience with ISO and applicable regulatory guidance. Perform initial and final review of protocols and associated Change Controls, protocol deviations and CAPA.

* Ensure the QA – Technical Plant Quality groups successfully perform document review and approval activities to meet specified timelines. Documentation may include QC test records, Qualification & Validation records (Assay, Facility and Equipment), Environmental & Utility Monitoring and Computerized systems.

* Serve as Subject Matter Expert for change control and CAPA system. Provide QA support on change controls and CAPA. Lead and manage change control and CAPA proposal meetings.

* Review for execution approval of change controls and CAPA per applicable procedures and client agreements. Perform final review and approval of change controls and CAPA.

* Provide QA support, and guidance to team members on investigations related to assay qualification, facility, utility, equipment and process activities. Review and assess criticality of events/investigations.

* Work collaboratively with manufacturing, QC, Facilities & Engineering and cross-functional stakeholders to ensure adherence to the governing SOPs and Quality Directives

* Develop and cultivate quality culture into business practices and processes which support manufacturing activities

* Develop annual quality plan and audit strategy for the site.

* Support the development and implementation of the Quality System.

* Maintain knowledge of current industry standards for both FDA, EU and Global regulations

* Support QA Compliance activities as needed or assigned by the Quality Site Head. Support regulatory and client audits as required

How will you get here?


Bachelor’s Degree in Life Sciences or Chemical/Biochemical Engineering


* At least 7 years of Quality experience in a GMP pharma or biotech environment

* At least 3 years of supervisory experience with direct reports

* Must have Equipment Qualification and Process or Method Validation experience

Knowledge, Skills Abilities

* Strong knowledge of FDA/EMA/ICH/JP regulatory requirements applicable to pharmaceutical Quality Systems.

* Ability to apply GMP regulations and other international guidelines to all aspects of the position.

* Extremely high attention to detail and concern for standards

* Critical thinking with the ability to prioritize multiple projects simultaneously

* Sound knowledge of Computer System Validation as related to compliance

* Strong knowledge of QbD, Risk Based approach, and performing Risk Assessments

* Strong interpersonal and communication skills and the ability to work effectively in a diverse community.

* Proficient at public speaking, teaching, facilitating to peers, senior associates, and area management within their operational group.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


Posted: 2019-09-27 Expires: 2019-12-26

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Manager, QA - Plant Quality

Florida, NY 12010

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