Montreal, PQ, CAN
23 hours ago
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 providing oversight and manages compliance for the quality systems under their scope. This includes responsibility for deviations, CAPAs, change controls and product release. This role ensures regulatory compliance for all drug products, NHPs and medical devices and systems. The Manager acts as lead Quality on assigned projects to provide continuous improvement of Paladin systems and products. They assure compliance with current Canadian and international GMPs and other regulatory standards. **Job Description** + Lead operational team in the development, management, harmonization, and improvement of quality systems and procedures. + Make decisions on all aspects of quality systems under their scope, such as Change Control, Deviations, Investigations, Release and CAPA systems to assure compliance and timely and accurate completion of reported events. + Continuous improvement project lead. + Document and monitor KPIs under their scope. + Lead the QA batch release and distribution activities from the contract manufacturing, testing and packaging facilities, including non MRA requirements. + Lead the review and/or approve change controls received from suppliers or initiated internally and ensure timely closure. + Review, assess and approve internal or external deviations/investigations before product release. + Prepare and/or review controlled documents (e.g. SOP's) required for compliance. + Manage and coordinate QA staff and/or consultants towards the timely completion of assigned duties and responsibilities. **Your Profile** + Bachelor's degree in administration or in science. + 8+ years of experience working in a Quality role in a GXP environment in the pharmaceutical or medical device industry. + 2+ years' experience in production and people management. + Considered an expert in QA disciplines and expert understanding and knowledge of cGMP/ISO 13485 regulations. + Thorough understanding and experience in Root cause analysis, product release and change controls. + Ability to effectively lead teams in problem solving and continuous improvement. + 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/ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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