Associate Dir, CorpQ&CGFMR-GQC-GFMR S

Job Summary

Reporting to the Global Vice President, Quality and Compliance, the Associate Director, Corporate Quality & Compliance, Global Field & Market Response, provides quality oversight and overall management of critical incident escalations and market action programs. Interfaces with regulators and liaise with stakeholders across the business to support inspection readiness, regulatory commitments and market actions across the enterprise. This role is accountable to ensure that timely escalations and regulatory activities are completed ensuring integrity and accuracy of the CGMP information at Apotex. This position is responsible for establishing and enhancing escalation programs to ensure proactive/ effective execution, governance, and enforcement at all sites, affiliates and functional areas across Apotex.  Manage teams and facilitate and lead Apotex Escalation Committee meetings.

Job Responsibilities

• Provides leadership to the GFMR team to ensure appropriate quality and oversight of escalation events and regulatory activities across the enterprise. Leads, develops and maintains effective relationships with external Regulatory Agencies; business partners as well as internal stakeholders in order to ensure timely notifications and resolutions to discovered potential pre and post distribution product defects
• Manage the Regulatory Notification system to ensure notifications within committed time frames of potential defects for distributed products, and support adhoc communication with Health Authorities
• Participate, Coordinate in Inspection Readiness and continuous improvement initiatives across sites; review and develop regulatory authority communications globally and drive CAPA closure, audit effectiveness. Participate on cross-functional escalation events to ensure accuracy of information on escalation events and prepare appropriate summaries for executive review as per established timelines
• Provide support, direction during regulatory inspection; participate in the development, review, compilation and dissemination of public advisories and Health Care professional letters; regulatory authority responses and other communications.
• Leads and Manages the Recall system to ensure timely, complete product recalls are effectively employed. Manage global drug shortages prevention plan for identified essential medicines
• Develop and implement appropriate business processes and controls including SOPs, in order to maintain effective quality standards
• Represent Global Compliance during site and functional area inspections by Regulatory Agencies and external customers, where required
• Provides guidance on identification of potential root cause to complex and/or broader problems- develops solutions; implements action plans to mitigate risks, informing & escalating as required
• Make decisions, provides recommendations to senior management that have direct impact on commercial products and provide information/insight on regulatory requirements & stay abreast of changes. Provide technical and regulatory guidance to internal, external stakeholders to ensure overall quality and compliance
• 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; 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.

Job Requirements

• Education
  • B.Sc. in Chemistry, Biochemistry or a related science

• Experience
  • Minimum 8-10 years of experience in the GMP Regulated industry.