Job Description
Manager, Quality Services
Job Description Summary
At Paladin Pharma, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you!
This position requires a presence at our office located in St-Laurent, Montreal, two days a week, on Tuesdays and Wednesdays.
Reporting to the Director of Quality Services, the Manager is responsible for changes management, product releases, investigations and complaints management, license management, product launches, medical devices certification and quality management systems, application of GMP requirements and budget management.
The Manager establishes a culture of continuous improvement in quality and compliance by collaborating, building and maintaining effective relationships internally and with external stakeholders, manufacturers and service providers.
Job Description
- Supervise and coordinate Quality Services Team to ensure timely completion of assigned duties and responsibilities.
- Manage changes management, product releases, product quality complaints including investigations, deviations, non-conformance system and CAPAs.
- Manage the establishment licensing system, specific GMP requirements for product launches, ISO 13485 certification and related quality systems.
- Manage non-MRA requirements and product return process.
- Prepare and/or revise controlled documents required for compliance.
- Recruit, train, develop and retain a team of quality professionals to support key deliverables.
- Build employee development and improvement plans and help the team develop and improve their skills.
- Manage subcontractors for the Quality Services Department.
- Build effective alliances, partnerships and synergies across functions and corporate boundaries to ensure the highest standards of compliance and quality of Paladin's products, services and activities.
Your Profile
- Bachelor's degree in science.
- 8+ years of experience in a quality function in the pharmaceutical / biopharmaceutical industry.
- 3+ years' experience in people management.
- Excellent understanding of GMP/ISO13485 terminology, concepts, regulations, industry standards and trends and their application to complex problems.
- In-depth understanding of a wide range of manufacturing technologies and dosage forms.
- Ability to effectively lead teams in problem solving and continuous improvement.
- Detail-oriented, able to work both independently and as part of a team.
- Strong technical writing skills and a good command of general grammar and usage.
- Demonstrates excellent interpersonal skills.
- Bilingual (French and English) with excellent oral and written communication skills.
Paladin Pharma strives to offer a French-speaking work environment to all its Quebec-based employees. Although, as part of its francization program, Paladin Pharma has taken all reasonable measures to avoid imposing the requirement of English, knowledge, and proficiency in English for Manager, Quality services position is at an advanced level, particularly due to the need to communicate and collaborate regularly in English with English-speaking business partners and authorities outside the province of Quebec.
What We Offer
- Hybrid work schedule
- Benefits package on first day
- Retirement Savings Plan (RRSP)
- Employer contribution to employee RRSP (DPSP)
- Employee Assistance Program (EAP)
- Telemedicine program
- Employee Referral Program ($)
- Free gym on site
- Free parking
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
About Us:
Headquartered in Montreal, Canada, Paladin Pharma is a leading specialty pharmaceutical company focused on acquiring or in-licensing new pharmaceutical products for the Canadian market. Its dedicated employees have made Paladin one of Canada's pioneering specialty pharmaceutical companies.
Paladin is an operating company of Endo USA, Inc, a highly specialized pharmaceutical company that brings quality branded and generic products to patients through excellence in development, manufacturing, and marketing.
To learn more about us, visit our website at www.paladin-pharma.com/
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