Quality Project Leader

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Division/Site:

Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.

Discover Impactful Work:  

Manage a portfolio of Clients as the key contact for Quality related topics.  Ensure timely resolution of quality matters with the client through coordination and collaboration of internal functional resources, while protecting product quality and patients’ safety.  Perform as Quality Approver for Quality Systems Records, Annual Product Reports, Validation Documentation, among other items.  Identify/participate/lead initiatives in support of quality risk remediation/mitigation or continuous quality improvement.  

Day in the Life:

• Perform as the key contact for Quality related topics for a portfolio of Clients.  
• Ensure 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. 
• Attend client meetings as Quality representative to provide guidance and strategic approach on quality related matters. 
• Support timely quality decision making related to projects/clients, and work with management to resolve quality related matters. 
• Prepare and present quality presentations for Client meetings. 
• Ensure site and client adherence to the terms of Quality Agreements in support of efficiency, effectiveness, and compliance.  
• Communicate issues that potentially affect product quality/compliance to the attention of Site Leadership.  
• Manage Quality Approvals and timeliness of Investigations (Deviations/Out of Specifications/Out of Trends/Complaints), CAPAs, Effectiveness Checks, Validation Protocol/Reports, Change Controls, Technical Transfers, Annual Product Reports. 
• Participate in/Facilitate the content of Quality Huddles (e.g., OOS Huddle, Deviation Huddle, Complaint Huddle, Department Huddle, etc.)  
• Identify Quality Risks for addition to the Site Risk Register and support risk remediation / mitigation as Quality Lead. 
• Recommend and lead Continuous Site Quality Improvements.  
• Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the function of a Quality Project Leader.  Talk to auditors during inspections to ensure information is provided in a timely, accurate, and complete manner. 
• Lead Quality initiatives and provide quality assessments on process improvement activities such as Mini Transformations or Kaizens 
• Perform other duties and support special projects as assigned.  

Keys to Success:

Education:  

B.Sc. Chemistry or Biology or related field 
 

Experience:  

Minimum 8 years’ experience in Quality Assurance or Compliance position within the pharmaceutical industry.   

Experience writing investigations.  

Previous Supervision and/or leadership experience (an asset). 

 
Equivalency:  

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

Knowledge, Skills, and Abilities: 

Thorough knowledge of current Good Manufacturing Practices and Standard Operating Procedures.  Ability to develop solutions that are mutually beneficial to the client and to Thermo Fisher.  Possess a highly developed quality, regulatory and production mindset with an appreciation for client service and the contract manufacturing industry.  Proven leadership and problem-solving abilities. Ability to prioritize multiple project deliverables and ability to adapt to a changing environment quickly and easily. Ability to motivate and influence.  Strong self-motivation.  Ability to work independently, and within a team environment with strong follow up skills.  Organized and detail oriented.  Excellent written and verbal communication skills.  Demonstrated computer proficiency with Microsoft Office programs.  Proficiency with the English Language. 

Physical Requirements:  

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area.  There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally. 

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided
• Must be legally authorized to work in Canada
• Must be able to pass a comprehensive background check

Compensation

The salary range estimated for this position based in Canada is $85,500.00–$128,250.00.