Associate Director, External R&d Quality

2 weeks ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
The Associate Director, External R&D Quality is responsible for developing and implementing Quality Systems to ensure products manufactured, tested and packaged by third party organizations on behalf of Apotex meet the applicable regulatory requirements as well as conditions of the Quality Agreement and Apotex quality standards. The incumbent will provide internal and external stakeholders scientific, technical and compliance expertise relating to the development of biopharmaceutical/pharmaceutical products of various dosage forms.

**Responsibilities**:

- Monitor quality aspects at third party organizations to ensure that the business is in compliance with GMPs, the QA Agreements, regulatory requirements and Apotex standards.
- Ensure that the quality aspects at third party organizations are in compliance throughdevelopment to commercialization: including lab and pilot scale development, clinical manufacturing and analysis, process and analytical characterization, validation through regulatory activities related to submission and approval.
- Oversee the review and final disposition of non-commercial batches for clinical studies manufactured by a third party organization on behalf of Apotex.
- Supportaudits of third party organizations and support regulatory inspections as required
- Responsible for managing Quality Risk assessments, as well as monitoring the execution of remediation plans to ensure that issues are suitably addressed.
- Works collaboratively with both internal and external stakeholders to resolve quality issues as well as maintain compliance. Provide input into investigations and deviations
- Represent R&D QA at technical meetings and establish good working relationship with clear communication and defined actions and goals.Act as point of contact for Quality issues during development.
- Represents R&D QA on cross functional teams during product launches and/or transfers from R&D to External Quality.
- Oversee the review and approval of controlled documents as required, including protocols, reports, document changes, master batch records.
- Liaise with management and escalate issues where “for cause” audits may be required
- Implement performance management and development strategies for R&D QA staff to encourage increased productivity and effective performance.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
- Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
- Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- All other duties as assigned.

**Job Requirements**:

- Education
- B.Sc in Chemistry, Biochemistry, Microbiology or a related science.
- Knowledge, Skills and Abilities
- Strong knowledge of GMPs,including Part 4 is preferred
- Strong knowledge of aseptic processing and sterile durg product requirements is required
- Strong interpersonal skills and the ability to communicate effectively with people in diverse settings.
- Excellent verbal and written communication. Ability to communicate complex technical and regulatory information concisely.
- Ability to effectively work both independently and in a team environment.
- Experience
- Minimum of 10 years of experience in the biopharmaceutical/pharmaceutical industry, 5 years in Quality Assurance and 3 years of management experience.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodatio

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