Director, Quality Services

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Director, Quality Services

Apply locations Quebec - Montreal time type Full time posted on Posted Yesterday job requisition id R001452

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 Vice-president of Scientific Affairs & Operations, the Director of Quality Services is responsible for internal and external quality services and systems, such as audits, complaints, training, product release, change controls, deviations, maintaining establishment licenses and general compliance, and helps assure compliance with current GMPs and regulatory agencies.

Job Description

• Operates an internal inspection program to identify and address potential Quality Management System design and execution risks and deficiencies.
• Collaborates with Supply Chain, Technical Services, Regulatory Affairs leaders to developing and implementing strategies and tactics that reduce the risks to, and assure the continuity of on time in full supply to patients of safe, pure, efficacious, high quality and fully compliant medicines.
• Oversees the maintenance of site Licenses for pharmaceuticals, medical devices, natural health products, controlled substances and narcotics.
• Manages Paladin quality team and subcontractors for Quality Services Departments.
• Lead development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards.
• Build effective alliances, partnerships, and synergies across functional, geographic and company boundaries to ensure the highest standards of compliance and quality of Paladin products, services, and activities.
• Liaise with third-party manufacturers, Health Canada, and any other regulatory authorities.

Your Profile

• Master’s degree in science.
• 10+ years’ Quality function experience in pharmaceutical / biopharmaceutical industry.
• 5+ years of people management experience.
• Demonstrated expert understanding of cGMP/ ISO13485 terminology, concepts, regulations, industry standards and trends and their application to complex problems.
• Demonstrated comprehensive understanding of a broad range of manufacturing technologies and dosage forms.
• Detailed understanding of problem-solving techniques and continuous and with the ability to effectively coach on effective problem solving and continuous improvement.
• Detailed understanding of the importance of Organization Culture to Patient Safety and Satisfaction, Business Compliance, Product Quality, Data Integrity and Employee Performance.
• 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 the position of Director of quality services is at an advanced level, particularly due to the need to communicate and collaborate regularly in English with English-speaking Business Partners and Regulatory authorities outside the province of Quebec.

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/

Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

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