General Manager,3rdPartyOps India-GQC-GEMQ A

Apotex Inc.  Mumbai, Maharashtra, India

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 Global Director, External Mfg Quality, the General Manager Third Party Operations provides quality oversight of products manufactured for Apotex by third party manufacturers. This role is accountable to ensure that products manufactured for Apotex are manufactured in accordance with cGMP, regulatory requirements and meet Apotex’s internal quality standards. This role interacts with high level management at third party manufacturers and acts as an Apotex representative. The role entails developing relationships, negotiating issues, and communicating Apotex quality requirement with third party manufacturers. There is significant interaction with many internal business and manufacturing organizations, and it will be necessary to work closely with cross functional teams such as Co-Development, Business Development, New Product Launch teams and Regional External Quality teams.

Job Responsibilities

  • Liaises with internal quality functions and other External Quality teams on issues relating to third party manufacture. Acts as primary contact with third party manufacturers on GMP issues and liaises with third party manufacturers supporting resolution of product quality issues.
  • Establishes a strong relationship with third party organizations. Implements quality systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks.
  • Ensures third party manufacturers within in the EMQ India Hub comply with the terms of the quality agreements. Perform periodic reviews with third party manufacturers and ensures updates are implemented.
  • Receives notifications of significant quality incidents from third party manufacturer and agree on actions as required. If necessary, initiates Incident Escalations. Collaborates closely with Regional External Quality functions on incident resolution.
  • Provides oversight of third-party manufacturer’s investigations into customer complaints, quality incidents and deviations, to ensure root cause are identified and effective CAPAs are implemented.
  • Implements and applies a risk-based approach to third party manufacturing operations quality oversight and seek efficiencies in operations without compromise to product quality. Promotes continuous improvement activities.
  • Assures the quality and compliance of New Product Supply by participating in and supporting due diligence assessments, technical transfer, and BD projects within the region. Responsible for Quality oversight of technical transfer operations in the region.
  • Oversees the regulatory and compliance status of products manufactured by third party manufacturers. Assures changes that impact Apotex products are evaluated appropriately and approved as per procedures. Ensures adherence to local compliance requirements.
  • Works with internal and external stakeholders to ensure that Third Party Strategy is developed in accordance with Regulatory and GMP requirements. Contributes to the development and improvement of External Quality Operations.
  • Perform all work in accordance with all established regulatory, 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.
  • 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
    • A minimum of a bachelor’s degree in microbiology, Chemistry, Pharmacy, or related science is required.
  • Knowledge, Skills and Abilities
    • Comprehensive knowledge of global cGMP and QA/QC systems associated with the manufacture of human drug products.
    • Experience of managing the day-to-day quality issues in a drug product manufacturing plant.
    • Able to act independently to take initiative and proactively seek resolution of quality issues.
    • Excellent organizational skills, analytical thinking, and inter-personal communication skills.
    • Demonstrates personal leadership and accountability. Able to prioritize work for self and others and can accomplish work through others.
    • Must be able to travel frequently and occasionally with short notice to visit clients and third-party manufacturers within the region.
  • Experience
    • Minimum 10 years’ experience is required in pharmaceutical industry with relevant QA/QC/Manufacturing experience preferably with multiple dosage forms, which would include a minimum of 8 years applicable QA 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 accommodation.

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