Associate Director, Quality Operations

Job Summary

The Associate Director, Quality Operations is a senior member of the Quality Team and is responsible for continuously improving overall Quality Operations at the Apotex Richmond Hill manufacturing site.

Reporting to the Senior Director, Quality, the Associate Director, Quality Operations oversees Material and Product Disposition, Quality Investigations, Quality Assessment and Approval of Quality Management System Records, the Controlled Substances Program, and is responsible for compliance escalations and regulatory reporting of critical events, in accordance with GxP, regulatory standards and company policies and procedures.

The Associate Director, Quality Operations is accountable and provides strategic direction for the functional areas within Operational Quality (OQ) Department and diligently manages activities and resources to support the business needs in compliance with regulatory requirements.

Job Responsibilities

• Overall responsible for Quality activities which support regulatory compliance and business requirements at the manufacturing site:
  • Provide visible, results oriented leadership that supports Apotex’s Mission, Core Values and strategic plan.
  • Implement internal quality procedures ensuring adherence to Global Quality Policies, Standards Operating Procedures and GMP’s.
  • Establish and maintain Quality performance metrics that support the corporate and site specific quality goals.
  • Be an active member of the Quality Management team and support a team environment within all segments of Quality.
  • Represent Apotex position and policy during regulatory/customer audits in relation to material/product disposition, quality investigations, quality management system records, and controlled substances
  • Participate actively in Quality forums and drive actions as needed to remediate compliance risks.
  • Support best practice sharing, harmonization, standardization and continuous improvement of quality mind set across the Apotex organization.
• Lead actively the department by maintaining a sustainable Quality Culture, and collaborating cross functionally within the Site Quality Organization for alignment and consistent messaging.
• Oversight of Investigations Management, ensuring site quality investigations are handled in a compliant and efficient manner.  Ensure product status and dispositions related to investigations are made visible and support business needs while maintaining compliance and appropriately assessing SISPQ.
• Accountable for overall QA Material/Product Disposition activities and documentation, which support the business and GMP compliance needs of manufacturing and distribution. Responsible to provide quality support for logistics, distribution and warehouse activities at the manufacturing site.
• Oversight of quality approval for quality management system records (i.e., investigations, CAPAs, Change Controls, GMP Forms, Protocols, Reports, etc.), ensuring skilled resources are in place to provide quality approvals with the appropriate experience and skill set to support compliant decision making in alignment with business needs.
• Responsible for compliance escalations and regulatory reporting of critical events, in accordance with GxP, regulatory standards and company policies and procedures (FAR, SIRC, AEC) as well as leading the recall process at the site as required.
• Oversight of the Controlled Substances Program at the site, ensuring skilled resources are in place to provide compliant oversight. Ensure GMP activities are well understood and continuously improved to support sustainability and compliance.
• Develop and maintain thorough knowledge of GMP requirements as they relate to the manufacturing of non-sterile and sterile pharmaceutical products, in addition to controlled substances.  Ensure Quality processes reflect current GMP requirements that best support regulatory compliance and the business.
• Ensure GMP activities are well understood and continuously improved to support sustainability of operations through the manufacturing/packaging processes; and a continual state of inspection readiness is maintained at all times.
• 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.

Cont'd

• 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 – Integrity, Teamwork, Courage and Innovation.
• 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

• Knowledge, Skills and Abilities
  • Strong understanding of GMP requirements and their application in a sterile and non-sterile production environment, as well as controlled substances requirements
  • Strong organizational, interpersonal and communication skills
  • Exhibited business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions
  • Demonstrated strategic, process-driven, analytical, and critical thinking
  • Proven experiences in holding people accountable, developing cross-functional teams, and facilitating decision-making processes
  • Proven ability to lead, manage and motivate subordinates
  • Demonstrated interpersonal savvy and relationship management/networking skills
  • Strong ability to deal with ambiguity and manage through difficult situations
  • Proven ability to manage multiple, complex projects at the same time
  • Excellent ability to delegate and affect change through others without direct involvement
  • Exercise innovative tactics and encourage others to demonstrate
  • Strong written and oral communication skill

• Experience
• Minimum 10 years of quality assurance experience in the pharmaceutical industry
• Minimum 7 years of leadership and people management experience in a quality role.
• Experience in Sterile and Non-Sterile Pharmaceutical Production Operations and controls, Investigations, CAPAs, Change Control, Material Release, Batch Release, Controlled Substances; as well as leadership, influencing, and negotiation.