**Job Description Summary** Temporary position for a period of 12 months 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 Manager, Quality Services, the Senior Specialist is responsible for leading assigned systems, assists in managing the quality system functions, provide expert quality guidance on audit program, training program and document management system. This person also asses’ new regulations and compendial updates and lead related projects and cross-functional teams. This person leads self-inspection/external audit program and observations follow-up/closure and maintains the Inspection Readiness plan for the site. **Job Description** + Support in resolving investigations, deviations, corrective actions, and other quality issues with each Contract Manufacturing Organization (CMO). + Assist with all aspects of quality systems such as redaction of risk assessment and approving major change controls, deviations, and investigations. + Evaluate metrics to determine trends and opportunities for continuous improvements and liaises with other departments. + Propose solutions and resolve regulatory or registrar clarification requests. + Support implementation and/or recommend business or compliance options and best practices to improve products, processes or services. + Provide consultative support in the preparation for regulatory inspections, quality technical agreements, internal and external audits, validation activities and special projects. **Your Profile** + Bachelor's degree in science. + 8+ years of experience working in a Quality role in a GXP environment in the pharmaceutical industry. + Expert knowledge and application of the principles, concepts and theories of Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs), GXP/ISO terminology, concepts, regulations and industry standards. + 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 Senior Specialist position is at an advanced level, particularly due to the need to communicate and collaborate regularly in English with English-speaking business partners 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.