Compliance Monitoring & Testing Manager H/F

Compliance Manager

This position is 100% on-site at the Strathroy site.

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.

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 OOSs 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
Bachelors degree in relevant scientific or engineering discipline is required

• 3 years of management experience in the pharmaceutical industry required; Knowledge and experience in dosage forms involving gelatine encapsulation is a definite asset.
• 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.
• Currently Catalent does not participate in the Ontario Immigrant Nominee Program (OINP).
• Occasionally the position requires standing walking reaching bending twisting stooping kneeling crouching or crawling alongside close vision capabilities and potential exposure to chemicals.

Comprehensive Benefit Package (Health Dental Vision & Life Insurance)
Group Retirement Savings Registered Pension Plan (RPP) with employer contributions.
Opportunities for professional and personal development & growth including tuition reimbursement.

Join the global drug development and delivery leader and help us bring over 7000 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. personal initiative. 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 . This option is reserved for individuals who require accommodation due to a disability. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.