Director of Quality, Consumer Health Canada

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 and compliance, 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
- 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