Associate Director, Quality & Compliance (Florida)

Job Summary

Reporting to Senior Director, Global Quality Services, the Associate Director, Quality & Compliance at the Apotex Corp office is responsible to provide Quality & Compliance oversight of cGMP and Drug Enforcement Administration (DEA) related activities for all Apotex United States Operations.

The Associate Director, Quality & Operations is accountable for all Quality & Compliance related activities/decision making and provide strategic leadership to the functional areas within Apotex United States Operations.

This role would also be part of site leadership team at both Indianapolis Distribution Center and Apotex Corp office and is responsible for audit readiness of Apotex United States Operations.

Responsible for overseeing Customer Complaints by triaging and working with the manufacturing sites to investigate and provide customers with the outcome of the complaints.

Job Responsibilities

• Overall responsible for Quality activities which support regulatory compliance and business requirements at Apotex United States Operations:
  • Provide visible, results oriented leadership that supports Apotex’s Mission, Core Values and strategic plan.
  • Lead and role model the Quality Culture mindset.
  • 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 Apotex United States Operations quality goals.
  • Be an active member of the Global Quality Compliance Management team and support all Quality & Compliance enhancement initiatives.
  • Represent Apotex position and policy during regulatory/customer audits in relation to material/product disposition and quality investigations.
  • 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.
  • Responsible for compliance to DEA regulations on the storage and distribution of controlled substances.
• Responsible for managing the team that receives the customer complaints, timely follow up with the respective manufacturing sites, complaint sample returns, follow ups and complaint resolution. This position encompasses a much broader understanding of TrackWise and SAP systems for all aspects of and Quality Complaints.
• Responsible for maintaining relevant Quality & Compliance related procedures, updates, GMP training of all Apotex United States Operations.
• Oversight of Investigations Management, ensuring all Apotex United States Operations 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.
• Accountable for overall Product Disposition activities and documentation, which support the business and GMP compliance needs of finished product distribution across United States. Responsible for providing senior quality leadership support for logistics, distribution and warehouse activities at the Indianapolis Distribution Centre.
• For all People Leaders:
  • 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 Winning Behaviours – Individual Accountability, Rigor & Discipline and Continuous Improvement.
  • 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 manufacturing and distribution environment
  • Knowledge of international GMP 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 skills
• Experience:
  • Minimum 10 years of quality assurance experience in the pharmaceutical industry
  • 7-10 years of leadership experience preferably in a quality assurance role
  • Experience in Pharmaceutical Manufacturing operations and controls, change management processes, regulatory affairs, validation, leadership, influencing, and negotiation