Director of Quality, Consumer Health Canada

Catalent Pharma Solutions; Strathroy; On-site; CAD 120,000 - 160,000; Full time

Job summary

Catalent Pharma Solutions seeks a Director of Quality for its Strathroy, Ontario facility specializing in consumer health products. This leadership position entails ensuring compliance with cGMP regulations, overseeing quality assurance processes, and leading a dedicated team to enhance product safety and efficacy. Candidates should possess a strong quality assurance background and leadership experience within the pharmaceutical sector.

Benefits

Comprehensive Benefit Package

Group Retirement Savings with employer contributions

Paid Time Off Programs

Employee Reward and Recognition Programs

Opportunities for professional and personal development

Qualifications

• 8+ years’ experience in quality assurance and compliance.
• Strong knowledge of Canadian, US and EU regulatory guidelines.
• Career experience with established contract manufacturing organizations preferred.

Responsibilities

• Ensure compliance with cGMP and manage quality systems.
• Mentor and lead quality personnel and initiatives.
• Make final decisions regarding product quality.

Skills

Leadership

Organizational Skills

Quality Assurance

Compliance Knowledge

Education

Bachelor’s degree in Life Sciences

Master’s Degree

Job description

Director, Quality, Consumer Health – Canada

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Strathroy, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.

Reporting to the Vice President Quality, Consumer Health and as a member of the Canadian Site Leadership Team this position is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The Director of Quality will work closely with the SLT, their direct reports and federal regulators in the development, roll-out and management of corporate policies through compliance needs and current Good Manufacturing Practice (cGMP) guidelines. They will also ensure through their oversight of their team, that site-specific quality systems and procedures for submitting research and development data (technology transfer), conducting investigations, generating site and corporate quality metrics are established and followed. It is through their personal and team’s efforts, that both internal customers and external regulators will view the Canadian Catalent Quality Systems and team positively.

Catalent is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

• Responsible for ensuring that the necessary systems are in place to support compliance with cGMP for the Canadian Catalent facilities, processes and people for the markets in which its products are sold.
• Ensure compliance assessments of Catalent Ontario are appropriately managed and that responses to resolve deficiencies are provided and communicated in a timely manner.
• Final decisions regarding product quality and on product disposition.
• Mentor, lead and provide adequate, trained personnel to support the production and packaging activities and the testing of raw materials, components, and labeling, intermediate and finished goods in line with the supply plan.
• Ensure that the direct and support responsibilities of the Quality groups are delivered in a cost-effective manner and appropriately balance risk and reward.
• Provide leadership within Quality for cross-functional initiatives aimed at improving corporate efficiency and effectiveness.
• Establish individual performance expectations for direct reports and regularly evaluate their performance against objectives.
• Other duties as assigned.

Shared Responsibilities:

• Ensure Quality representation for the supply planning portion of the S&OP process and other PLCM events (eg. planned changes).
• Ensure alignment of Quality, Operations, and Product Development on key
• All other duties as assigned

The Candidate:

• Bachelor’s degree in Life Sciences or related field required. Master’s Degree preferred.
• 8+ years’ experience with increasing levels of responsibility and leadership in quality assurance, compliance and quality control.
• Strong knowledge of Canadian, US and EU regulatory guidelines, agencies and their senior contacts/people.
• Extensive relevant experience in pharmaceutical manufacturing. Knowledge of local, provincial, federal regulations and laws governing business operations of a pharmaceutical manufacturing facility.
• Career experience with established contract manufacturing organizations is preferred.
• Excellent management and organizational skills. Demonstrated ability to lead a team and achieve results.
• Experience in budgeting and proven ability to manage multiple projects and meet deadlines. Quality Processes and issues.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Why You Should Join Catalent:

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

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.

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 [e-mail]. 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.