Quality Assurance Compliance Manager

Quality Assurance Compliance Manager

Position Summary :

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.

Your talents, ideas, and passion are essential to our mission : to help people live better, healthier lives. 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.

Reporting totheDirectorof Quality, Consumer Health Canada, thisposition isaccountableforthe management, monitoring,improvement, and development ofQuality Systems andprogramsthatare applicable to allcompanysitesandtheStrathroyCompliance Program, toensurecontinuing adherence to regulatory andcustomer cGMP standards.

Specifically, thisposition hasdirect oversight of the CommercialProductstability,SOP,ChangeManagement,MasterDocumentMaintenanceandControl, Annual Product Review, and Customer Complaint Investigation programs.

This position can be located in Strathroy, Ontario or Windsor, Ontario, our 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.

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

The Role :

Host and directly manage Regulatory and Customer audits. Prepare and facilitate responses to the observations arising from these audits and manage the follow up and closure of the corrective actions.

Manage the Strathroy and corporate self-inspection and compliance monitoring program.

Lead the implementation of new, and improvement of existing, Quality Systems to ensure these are both compliant and effective, with a particular focus to the development of systems for newer service offerings as they are introduced, and emerging trends in existing systems.

Manage the Commercial drug product 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.

The program allows for the provision of scientifically valid data 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 it able to identify, prioritize, and quantitate the most significant outgoing 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 and provide oversight for the Annual Product Review program ensuring deliverables are on time and value-added time a process knowledge and control perspective.

Work closely with the operations team to ensure that the Quality Management System and Quality Plan supports current Quality Management strategy theories, corporate objectives and industry requirements and develop and deliver enhanced and effective cGMP Training.

Develop and maintain metrics to measure effectiveness of key Quality KPIs.

Other duties and projects as assigned.

The Candidate :

Bachelor's Degree in a pertinent Scientific or Engineering field is required.

5+ years of management level experience in quality related roles for consumer health products is required.

Experience working in a manufacturing, pharmaceutical and / or GMP facility is preference.

Knowledge and experience in dosage forms involving gelatin encapsulation is an asset.

Understanding of the overall business needs and objectives

Expertise in contemporary tools to meet current and advancing cGMP requirements.

Excellent verbal and written communication skills.

Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and HPFBI inspections.

Ability to multi-task and prioritize.

Ability to respond quickly and to a changing regulatory environment

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 & personal time.

Employee Reward & Recognition programs.

Opportunities for professional and personal development & growth including tuition reimbursement.

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.

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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. 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.