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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, Quality Services is responsible for providing oversight and support to the quality systems at Paladin. This includes involvement in technical transfer and validation initiatives, deviations, CAPAs, change controls, complaints, audits, stability, training, product release and APQRs. This role involves the maintenance of compliance for all products and systems at Paladin. The person acts as lead Quality support on project(s) assigned by managers to maintain and provide continuous improvement of Paladin systems and products. Finaly, the manager assures compliance with current domestic and international GMPs and regulatory agencies.

This role will work with cross-functional departments and suppliers for the completion of documentation related to our quality systems and batch release.

Job Description

• Contribute to the development, management, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP/ ISO 13485 activities.

• Assist with all aspects of quality systems, such as Change Control, Deviations, Investigations, complaints and CAPA systems to assure compliance and timely and accurate completion of reported events.

• Supervise the QA batch release functions for cGMP commercial and distribution activities from the contract manufacturing, filling, testing and packaging facilities. Including non MRA requirements and product return process

• Prepare and/or review controlled documents (e.g. SOP's) required for compliance.

• Supervise and coordinate QA staff and/or consultants towards the timely completion of assigned duties and responsibilities.

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/ISO 13485 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/

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.