Mylan Pharmaceuticals ULC

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Manager, GMP and Regulatory Compliance role will make an impact:

Key responsibilities for this role include:

• Manage internal audit and customer complaint programs (including development and integration with global systems) to ensure compliance with GMP’s and exercise due diligence with regards to corporate responsibilities to consumers.

• Review and approve procedural documents (SOPs, change controls) and maintain in good order records relating to the auditing of company operations ensuring compliance with the record retention schedule.  Responsible for the management of the change control, SOP and GMP documentation management systems.

• Serve as co-host and provide preparatory support to site operations during regulatory and third-party inspections.  Document findings and evaluate the potential ramifications of audit findings in order to provide management with evaluation of the business risks associated with non-compliance with local and international regulatory requirements.  Track and trend audit observations and CAPA ensuring appropriate follow up with all concerned parties.

• Assist in the implementation of pertinent quality improvement initiatives including the generation of Quality Technical Agreements to ensure responsibilities of Mylan ULC and contract manufacturers/testers and packagers are clearly defined and mandated. Provide support, where required, to the Business Development and Legal groups in the evaluation of third party business and preparation of commercial supply agreements.

• Translate applicable regulatory and GMP requirements, as well as customer’s requirements, into Quality systems and ensures communication of these to appropriate site personnel ensuring final disposition is acceptable.

• Responsible for the maintenance of site regulatory licenses (Drug Establishment Licenses, Natural Health Products, Medical Devices) in a state of continuous compliance with regulations.

• Support the negotiation of Quality Technical Agreements ensuring timely review and approvals by all parties.  Review and approve Annual Product Reviews.

• Coach and develop compliance staff in order to ensure sufficient backup and depth while creating an efficient and motivated department with high standard of performance.

• Manage the departmental expenses in line with the approved budget and provide information required for budgeting purposes.

• Perform other duties as assigned.

The minimum qualifications for this role are:

• Bachelor's degree or equivalent-Biology, Chemistry, Applied Science.

• 5 years Pharmaceutical industry experience.

• 2 years of Prior Management experience.

• Cross-functional experience in all GMP areas to gain thorough understanding of the quality and its impact on the business model and objectives. Experience in the regulatory framework of the pharmaceutical industry.

• Excellent knowledge of Good Manufacturing Practices and Canadian Health Authority regulations, policies and directives.

• Superior understanding of manufacturing and packaging processes, laboratory testing requirements.

• Knowledge and appreciation of the global dynamics and versatility across the Mylan group of companies.

• Intermediate/superior proficiency in the use of Microsoft Office applications.

• Ability to assess problems with multiple, complex variables through non-standardized solutions that require independent judgment and analysis.  Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems. Extensive technical problem-solving skills and ability to identify and analyze trends.

• Strong leadership, mentoring, conflict resolution and consensus gathering skills.

• Strong assessment and analytical skills (risk assessment and mitigation).

• Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. 

• Excellent time management and organizational skills, complimented by superior verbal, written and team playing abilities.

• Sedentary.  Minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.

• Can understand technical documents and can communicate description of problems and solutions.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, gender identity, gender expression, age, record of offences, marital status, family status, disability or any other characteristic, protected by local, provincial, or federal laws, rules, or regulations.