Quality System Manager/ DI Officer

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?
The Quality Systems Manager is responsible for the oversight of the Quality Management System (QMS) and QA Document Control functions at the Alachua, FL site of Viral Vector Services. The incumbent will be the site Data Integrity Compliance Officer and Digital Quality lead. Ensures GxP systems are in compliance with industry regulations, corporate data integrity standards, documentation practices and procedures as related to both paper and electronic records. Ensures quality data reporting for the department and site. Represents IT quality on all System Life Cycle deliverables and activities.

What will you do?

• Oversight of the QMS, including Deviation, CAPA, Change Management, Quality Management Review (QMR}, Document Management, and providing training on QMS.
• Trend on KPls to monitor the effectiveness of processes within the quality system and report at a quarterly management review.
• Lead and mentor team. Evaluate, schedule and balance departmental workload with respect to assignments, responsibilities, personnel and management of projects
• Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry and Company standards.
• Establishes operational objectives and assists with developing, modifying and executing Company policies.
• Coordinates procedure/process testing and ensures reviews of audit trails.
• Provides gap assessments and status updates to senior management to maintain and improve data integrity.
• Supports risk assessments and risk-based methodology to resolve high risk equipment and systems, and determines appropriate corrective action.
• Leads departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity.
• Develops, manages, and updates procedures to ensure there is clear direction and understanding regarding awareness, responsibilities and the importance of corporate and regulatory requirements for data integrity compliance.
• Leads and establishes a surveillance program to audit all laboratory and operational practices and staff for compliance with established documentation and data integrity standards, practices and procedures
• Approve system life cycle deliverables (SDLC) and activities to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is collected and reported to support SDLC activities for assigned IT systems, including associated change requests
• Represent IT Quality on all assigned projects in support of SDLC activities.
• Reviews, authors and approves SDLC deliverables and activities in regard to company SOPs, policies and current regulations
• Provide guidance and support to IT personnel in their SDLC efforts, to ensure compliance
• Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.
• Provide QA oversight for system related issues
• Act as a high-level technical resource to IT quality and customer base for interpretation of policy, review and approval of technical documents, and high-level decision making
• Support internal and client audits and regulatory inspections

How will you get here?
Education:

• Bachelor's Degree in Sciences, Engineering, IT or related field required

Experience:

• At least 8 years of Quality experience in a GMP regulated industry required
• At least 2 years of experience in leading teams required
• Complete knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP), including relevant FDA and EU GMP regulations.
• Experienced knowledge of laboratory instrumentation and/or operations equipment.

Knowledge, Skills, Abilities:

• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Effective written, interpersonal, and presentation skills.
• Ability to lead teams to drive functional, technical and operational excellence.
• Ability to inspire and foster innovation, collaboration, transparency and team efficiency
• Knowledge of IT Control methodologies, including GAMP5 and GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity
• Experience with system validation across GxP landscape, specifically GMP applications
• Knowledge of the IT system development life cycle and software quality assurance in a regulated environment
• Knowledge of risk-based methodology and application

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 90,000 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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