Quality Assurance Supervisor Jobs

Reporting to the Quality Manager, the Quality Assurance Supervisor is an essential member of the pharmaceutical manufacturing plant in Canada the Quality Assurance Supervisor will oversee the QMS Compliance Team, ensuring effective resolution of quality-related compliance issues. You will be responsible for managing quality systems to maintain GMP compliance, supporting the Strathroy site, and providing expertise in various quality-related areas. Additionally, you will review and approve controlled documents, support regulatory and customer audits, and oversee internal audits. As a leader, you will provide guidance, training, and support to team members while ensuring their compliance with company health and safety requirements. This role will play a key role in overseeing the day-to-day activities of the Quality Assurance teams. This includes managing testing procedures, ensuring compliance with cGMP (GLP) guidelines, and maintaining up-to-date specifications and methods of testing. Additionally, the Quality Assurance Supervisor will collaborate closely with cross-functional departments, including Operations, Validation, and Supply Chain, to address quality issues and ensure timely resolution.

This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.

Shifts: Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch

The Role

• Select and appoint new team members as needed, arrange training, conduct performance appraisals, and provide support and guidance to all team members.
• Provide support to the Strathroy site in various quality system areas, including supplier and material assurance, internal audits, customer regulatory inquiries, change control, document control, corrective actions, and metrics provision.
• Oversee the internal audit schedule, review internal audit reports, and provide support during regulatory and customer audits, ensuring readiness and compliance.
• Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met and perform other duties as required.
• Responsible for resource planning for the team based on information from the Master Production Schedule (MPS) and monthly commitment meetings and maintain close communication with Supply Chain, Purchasing, Validation, and Operations teams to address quality issues in a timely manner.
• Act as the Quality Expert for the review of change controls and protocols and Review and approve controlled documents to ensure compliance with quality standards and ensure compliance with Environmental, Health, and Safety (EH&S) regulations, demonstrating leadership in safety practices and resolving safety-related issues.
• Provide daily supervision of the Quality Assurance teams, including performance management, support for staff in achieving their personal development goals, conduct and document training for all team members and ensure they are adequately trained for their respective duties.
• Oversee the Strathroy supplier assessment program, reviewing supplier audit reports, complaints, and material reviews.

The Candidate

• Strong commitment to workplace safety and a thorough understanding of occupational health and safety regulations in Ontario. The candidate should prioritize employee safety, promote a culture of safety, and ensure compliance with safety protocols and procedures.
• In-depth knowledge of GMP compliance and regulatory requirements with a strong understanding of quality systems, such as supplier and material assurance, internal audits, change control, and corrective actions.
• Proven track record in supporting regulatory and customer audits, and proficiency in overseeing internal audit processes and conducting compliance reviews.
• Strong analytical and problem-solving skills to identify and resolve quality issues, optimize quality systems and processes, and drive continuous improvement. The candidate should be able to make informed decisions in a timely manner, considering both operational and regulatory requirements.
• Minimum 3+ years of experience in leading and supervising a team in a Quality Assurance environment, ensuring safety, quality, and productivity. The candidate should have excellent leadership, communication, and interpersonal skills to effectively manage a diverse workforce and foster a culture of continuous improvement.
• There is also the potential exposure to chemicals.
• Excellent communication skills, both written and verbal, to effectively collaborate with cross-functional teams, including quality control, supply chain, engineering, and other departments. The candidate should be able to communicate clearly and professionally with team members at all levels of the organization.
• Use of manual dexterity is required.
• Experience in reviewing and approving controlled documents.
• The employee is occasionally required to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl.
• Strong leadership skills with experience in managing and developing a team.
• Strong organizational and time management skills to prioritize tasks, allocate resources effectively, and meet operational schedules. The candidate should be able to handle multiple priorities and work efficiently in a fast-paced manufacturing environment.
• Strong computer skills including Microsoft Office Suite (Outlook, Excel, PowerPoint, Word) and familiarity with quality management systems and related software is advantageous.
• A bachelor's degree in a Chemistry, Life Science, Microbiology, or related scientific field is required.
• Excellent understanding of health and safety requirements and commitment to compliance.
• The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard.
• Vision abilities required by this job include close vision.
• Minimum of 3+ years of experience in a Quality Assurance role ideally within the Life Sciences industry is required.
• Ability to provide quality-based support and guidance for new product introductions and site projects.

Why You Should Join Catalent

• Opportunities for professional and personal development & growth including tuition reimbursement.
• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions
• Paid Time Off Programs including vacation, banked time & personal time.
• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Employee Reward & Recognition programs

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.