QA Manager, Complaints and Investigations

Work Schedule

Environmental Conditions

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:

The Manager of Investigations and Complaints is an integral member of the site Quality Organization that helps to catalyze a culture of quality and customer centric to enable excellence in quality performance, Right First Time, On time Delivery, and customer experience across Commercial and Pharmaceutical Development Services (PDS) businesses.

Essential Functions:

Ensures Customers and Patheon are operating in compliance of site and global SOP’s.

Provides oversight to Investigations and Complaints teams to ensure GMP compliance and OTD

Maintains Quality programs to ensure timely completion and quality of investigations and implementation of CAPA supporting Cincinnati Quality Metrics.

Responsible for site deviation trending and reporting per corporate compliance

Ensures Quality escalation and investigation processes are followed and improve processes as the need arises

Leads Quality related continuous improvement initiatives

Reviews and approved GMP documents including investigations, protocols, reports, and other documents which may require a quality signatory.

Supports regulatory inspections and customer audits

Support Cross-Functional Teams in quality owned results and customer concerns.

Ensures that products released to market meet quality, safety, and efficacy through the oversight of the batch disposition team.

Establishes meaningful metrics to manage performance and propose improvement solutions when required for Quality Project Leads (Increase CAS Score) and Investigations/Complaints (Decrease Cycle Times)

Coaches and develops QA staff to ensure a high-performance team

Education:

Bachelor of Science (B.Sc.) or equivalent managerial and quality related experience will be taken into consideration.

Experience:

Minimum 5 years of Quality Assurance experience within the pharmaceutical industry.

Minimum 2 years previous supervisory experience, with production experience considered an asset.

Knowledge, Skills and Abilities:

Outstanding Good Manufacturing Practices and United States Food & Drug Administration (FDA) compliance knowledge.

Ability to drive functional, technical and operational excellence.

Ability to encourage and cultivate collaboration, transparency and team efficiency.

Ability to think strategically with the ability to direct the resolution of technical problems using innovative ways.

Excellent interpersonal and communication skills (both oral and written).

Possesses highly developed quality, regulatory and production mentality

Capable of setting clear priorities, coordinating work, and making quality decisions in a fast-paced business setting.

Proven computer proficiency with Microsoft Office programs.

Proficiency with the English Language.