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Director, Quality & Compliance

APOTEX

This is a Contract position in Etobicoke, ON posted September 17, 2022.

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

Reporting to the Senior Director, Quality Operations, the Director, Quality & Compliance (“Director”), is responsible for the Quality function at Apotex’s Finished Dosage manufacturing facilities.
The Director, Quality & Compliance has oversight over all GxP activities and functions including Quality Operations, Quality Systems, Quality Control, Validation, Compliance and Capability. At the Liquid Dose sites, this includes oversight for sterile manufacturing processes, along with Microbiology. The Quality organization is an independent function and is responsible for making all final GxP decisions within their area of responsibility. The Quality decisions cannot be overruled.
The Director, Quality & Compliance, directs quality compliance and risk based evaluations and provides in-depth technical support for finished dose manufacturing processes, technology concepts and process development and QA validation activities to ensure that these departments support the divisional goals and strategic plans of Apotex.
The Director, Quality & Compliance has complete responsibility for all aspects of quality assurance and quality control at the site, making sure that the products released are fit for their intended use, comply with the requirements of regulatory filings, and do not place patients at risk due to inadequate safety, quality or efficacy.
The Director, Quality & Compliance monitors Government, Customer and Industry Quality system requirements to assure procedures are adequate and in compliance; oversees Regulatory Agency certification and periodic audits; is responsible for formulating, documenting, implementing and assuring compliance to Global Quality policies, plans and standards, and represents the site QA organization, among other duties.
Working Relationships:
This position reports to the Senior Director, Quality Operations and works closely with the Corporate Quality, Manufacturing, Supply Chain, Regulatory, Technical Operations and Project Management departments.

Job Responsibilities
  • Accountable for overall Quality and regulatory compliance at the Finished Dose site, resulting in a reliable product supply to customers through the Apotex Supply Chain.
  • Provides input or approval for facility, equipment and process design specifications, qualifications, validations and control programs. Proposes solutions and pushes the organization to resolve difficult problems and address knowledge and/or resource gaps. 
  • As the highest point of Quality issues escalation for the site, responsible for overseeing the assignment and completion of investigations, corrective/preventive actions and CAPAs; and escalating risks to Corporate Quality with a plan of action, mitigation and execution timelines. 
  • Play an active leadership role in maintaining a sustainable Quality culture at the Finished Dose site, and contribute to the development of quality policy for Apotex as a whole.
  • Represent Apotex to Regulatory Agencies through leading inspections and participating in Industry Groups in order to develop and influence industry standards with respect to overall operation processes and procedures.
  • Sponsor best practice sharing, harmonization and standardization, LEAN deployment and a continuous improvement mindset. 
  • As leader of the site Quality organization, provide an environment that enables and encourages all employees to contribute to their full potential. 
  • Develop, with Direct Manager, departmental expense, capital budgets and headcount projections. Track and manage expenditures and headcount to budget over the fiscal year.
  • Recruits, trains, develops and manages effectively the ongoing performance of their direct reports.
  • 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.
  • Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
  • Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
  • All other duties as assigned.
Job Requirements
  • Education
    • Bachelor of Science degree or related discipline; Masters degree is an asset
  • Knowledge, Skills and Abilities
    • Excellent leadership capability with demonstrated track record of leading the quality organization for finished dosage pharmaceutical products
    • Excellent communication, facilitation, presentation and technical writing skills
    • Advanced skills in solving complex problems, with the ability to bring issues to resolution
    • Advanced skills in handling multiple responsibilities, tasks and projects simultaneously, including ability to shift priorities
    • Demonstrate advanced ability to evaluate and apply compliance requirements/guidelines to complex situations
    • Demonstrate advanced leadership skills, with a focus on strategy and continuous improvement
    • Ability to interact with regulatory agencies
    • Advanced skills in leading, motivating, influencing, and negotiating with staff
  • Experience
    • 10+ years of experience in Pharmaceutical Quality Operations
    • 5+ years of experience in a management/leadership position
    • Experiential knowledge and application of Food and Drug Administration (FDA), Health Canada and other international regulations

Must have working background in a manufacturing facility, and knowledge of regulations and practices pertaining to pharmaceutical products

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 accommodation.