Description:
This position is located in Strathroy, Ontario, 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 Associate Director, Compliance, the Compliance Manager is accountable for the management, monitoring, improvement, and development of the following Quality Systems and programs that are applicable to the Strathroy and Windsor Compliance Program, Commercial Product Stability, Annual Product Quality Review, Customer Complaint Investigations, Training, and Strathroy site Audit Management. The Compliance Manager will ensure continuing adherence to regulatory and customer cGMP standards and foster a culture of continuous improvement within the Quality System to address changes in Regulatory expectations and landscape.
The Role:
- Host and directly manage Regulatory, Customer and Corporate audits at the Strathroy site. Prepare and facilitate responses to the observations arising from these audits and manage the follow up and closure of the corrective actions.
- Manage the Commercial Stability Program, ensuring compliant and efficient preparation of protocols, pulls of samples, execution of testing, investigations of OOS’s, and preparation and approval of reports to support shelf-life expectations and resulting shelf-life assignment decisions by the Customer/Client for Catalent manufactured products.
- Manage the Customer Complaint Investigation process, ensuring that the system functions to identify, prioritize, and quantitate the most significant product quality issues resulting in customer complaints and rejections. Establish and lead the company process improvement teams to address the product and process quality issues that have been identified.
- Provide oversight for the Annual Product Quality Review program ensuring deliverables are on time and value added from a process knowledge and control perspective.
- Manage the Ontario Training program administration.
- Develop and maintain metrics to measure effectiveness of key Quality KPIs.
- Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
- Performs other duties as assigned.
The Candidate:
- Bachelor’s degree in relevant scientific or engineering discipline is required
- 3+ years of management experience in the pharmaceutical industry required; experience in manufacturing or GMP environments is a plus.
- Knowledge and experience in dosage forms involving gelatine encapsulation is a definite asset.
- Understanding of the overall business needs and objectives.
- Excellent verbal and written communication skills.
- Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and Health Canada inspections.
- Ability to multi-task, prioritize and respond quickly to a changing regulatory environment.
- 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.
- Currently Catalent participates in the Ontario Immigrant Nominee Program (OINP) on a limited basis.
- The employee's role frequently involves sitting and utilizing hands and fingers for tasks such as handling, feeling, and keyboard manipulation, necessitating manual dexterity.
- Occasionally, the position requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, alongside close vision capabilities and potential exposure to chemicals.