Manager, QA
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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.

Summary:

Responsible for leading both Quality on the Floor and Records/batch release teams. This position reports to the Quality Operation Senior Manager. This persons time will be spent almost exclusively in manufacturing supporting issue resolution and providing oversight of the day to day QA activities in partnership with Operations while handling batch disposition in corroboration with Supply Chain. In addition, this role preparation for regulatory inspections and customer audits in the manufacturing space. Good understanding of cGMPs and regulatory requirements are essential.

Location: Cincinnati, OH - 2110 East Galbraith Road

Essential Functions:

Provide leadership to assigned staff by performing the following: lead organizational change; develop and empower staff; nurture relationships; put staff in a position to succeed by meeting their personal career goals while also achieving organizational goals.

Build effective teams that apply their diverse skills and perspectives to achieve common goals.

Drive engagement and build a climate where staff are motivated to do their best.

Assist in the development of goals and key performance indicators, providing leadership of Operations GMP activities for external Board of Health inspections, as they pertain to Operations

Assist in the development of Good Manufacturing Practices (GMP) for Operations.

Provide day-to-day support of Operations, through RAPIDs, deviation investigations, RCA, create effective CAPAs, real-time BPR review, logbook reviews, and overall Quality on the Floor.

Partnership with Operations Department Managers.

Maintain visible Quality metrics for QOTF department and hold organization accountable to deliver key results which include but are not limited to; reduction in BPR errors, reduction in Scrapped Batches, reduction in DI Reportable Events, and reduction of Deviation Rates.

Assist in the development of standard operating procedures (SOP's) and good manufacturing practices (GMP) training in regard to Operations activities.

Education:

Bachelor of Science (B.Sc.) is preferred, or 10+ years practical experience in the clinical manufacturing industry.

Experience:

3+ years proven track record in Pharmaceutical Quality Assurance and additional successful experience in Pharmaceutical Production.

Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills and Abilities:

• Thorough knowledge of OSD manufacturing, including equipment and process understanding.
• Ability to drive functional, technical and operational excellence.
• Ability to encourage and cultivate innovation, collaboration, clarity and team efficiency.
• Ability to drive and develop a strong quality culture
• Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Effective written, interpersonal, and presentation skills.
• Ability to work on multiple projects simultaneously with little supervision.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

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