Quality Project Leader

Job Description

Summary:

This role is responsible for managing a portfolio of Clients through support of quality performance, oversight of product transfers to Commercial operations and to approve deviation/OOS/OOT investigations, validation protocols/reports, and change controls. The Quality Project Leader (QPL) must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills, and excellent attention to detail. The QPL focuses on client facing activities including client experience and relationship management, Quality agreement negotiation and participating in client audits. In addition, this position provides QA support for the site Quality programs including rapid response to manufacturing incidents and investigation management.

Essential Functions:

• Manages a portfolio of Clients and will be the key contact for Quality related topics
• Prepares and leads quality presentations for Client meetings
• Quality oversight for Deviations and Laboratory Investigations, validation protocol/reports, change controls, technical transfers
• Recommends Quality improvements on site based on related trends from Quality systems
• Leads Quality initiatives and provides quality assessments on process improvement activities such as Kaizen events
• Ensures resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patients safety
• Supports decision making on projects and future directions
• Manages team member interactions with clients
• Participation in department meetings as necessary
• Supports PAI or Client Audits as necessary
• Assists with negotiation terms of Quality agreements with the client as required
• Works with and advises staff on administrative policies and procedures
• Provide QA support for Technical transfer Team and new equipment implementation

Education:

Bachelors Degree (required) in Chemistry, Biology, Engineering or relevant science is preferred.

Experience:

Minimum of 5 years experience in a senior Quality Assurance or Compliance position in the pharmaceutical industry is preferred.

Equivalency:

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

Competencies:

• Outstanding leadership skills; a demonstrated ability to motivate and empower.
• Ability to develop solutions that are mutually beneficial to the client and to Thermo Fisher.
• Ability to function independently and as part of a team.
• Superior communication and presentation skills, verbal and written, fluent in the English language.
• Demonstrated Commitment to our fundamental principles of Integrity, Respect, and Excellence.
• Experience writing and/or reviewing deviations and investigations
• Ability to quickly adapt to a changing environment
• Extensive knowledge of GMP
• Strong Proficiency in Microsoft Office Suites
• Ability to work on multiple projects simultaneoulsy
• Strong attention to detail