Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

Discover impactful work:

A key member of the site Quality Organization, responsible for fostering a culture of quality and customer-centricity to achieve excellence in quality performance, Right First Time, On-time Delivery, and customer experience across Commercial and Pharmaceutical Development Services (PDS) businesses.

Day in the life: 

Lead a team of Quality Project Leaders to ensure effective execution of quality initiatives.Ensure compliance with Quality Agreements between Company and customers.Enhance the Quality Culture at the site through initiatives such as "Right From Me" huddles, GEMBA, and other quality improvement programs.Provide oversight to Quality Project Managers to ensure exceptional customer experience and adherence to Good Manufacturing Practice (GMP) standards.Monitor and improve quality escalation and investigation processes as required.Lead continuous improvement initiatives related to quality.Review and approve GMP documents, including protocols, reports, and master documents.Support regulatory inspections and customer audits.Ensure timely release of products.Maintain Quality programs to ensure timely completion of investigations and implementation of Corrective Action Preventive Actions (CAPAs).Ensure that products released to the market meet quality, safety, and efficacy standards. Provide approval for the disposition of commercial and clinical study drugs for shipment.Support customers during site visits for business reviews and manufacturing.Develop and maintain quality scorecards for each Commercial and Development client, providing practical solutions to improve performance.Coach and develop QA staff to build a high-performance team.Promote a safe working environment, report potential hazards, and ensure compliance with Environmental Health and Safety procedures.Select, develop, and evaluate staff to ensure the efficient operation of the function, providing guidance on administrative policies and procedures.

Keys to success:

Education:

Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Biology.
 

Experience:

Minimum 7 years of Quality Assurance experience within the pharmaceutical industry.

Minimum 3 years of previous supervisory experience, with Production experience, is considered an asset.

Equivalency:

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

Knowledge, Skills and Abilities:

Exceptional Good Manufacturing Practices and United States Food & Drug Administration (FDA) compliance knowledge. Ability to drive functional, technical and operational excellence.  Ability to inspire and foster collaboration, transparency and team effectiveness.   Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches. Excellent interpersonal and communication skills (both oral and written). Possesses highly developed quality, regulatory and production mentality including an appreciation for client service and contract manufacturing. Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting. 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

OTHER

Relocation assistance is NOT provided.Must be legally authorized to work in CanadaMust 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.