Compliance Supervisor

Job Summary

The Supervisor, Compliance is a member of the Quality & Compliance management team and is responsible for the Internal Audit Program, Audit Readiness Program, and Risk Management Program at the Richmond Hill site.  This position is responsible to organize and lead Regulatory Audits, Corporate Audits, Customer Audits and oversee Internal Audits.  Responsibilities include the application of regulatory expertise and intelligence to day-to-day operations, maintenance of the Site Master File, gap assessment of Industry Regulatory Observations, oversight of Quality Culture Initiatives and the delivery of New Employee Onboard Training.  The Supervisor is also responsible to compliance report metrics, to support escalation of critical observations for the site, and for work scheduling, review and approval of documents, training, and employee development.

Job Responsibilities

• Lead the Compliance team and establish objectives to align with site and corporate objectives; maintain a high performing team and provide effective communication across functional groups to successfully deliver on commitments.
• Lead and manage the Site Audit Readiness Program and Risk Management Program to ensure the site is inspection ready for unannounced inspections at all times.
• Manage the Internal Audit Program and oversee functional walk-throughs to ensure compliance to site, corporate and regulatory requirements.
• Manage Regulatory, Corporate, and Customer Audits.  Interface with auditors and represent the site during audits while ensuring the operation of an efficient and effective Inspection Support Team inclusive of the inspection backroom.
• Oversee and assist in audit response development and review to ensure responses address the root cause with immediate actions, appropriate CAPAs to correct and prevent recurrence, and effectiveness verifications.
• Responsible for timely and effective execution of audit commitments.  Interact with subject matter experts in all functional areas to manager their response to observations and their timely commitment to address the findings within the quality system.
• Maintain awareness of regulatory intelligence, and perform regulatory gap assessments to identify site risks and ensure identification of actions within the quality system to address the gap.
• Oversee the Site Risk Management Program and ensure integration of this into Inspection Readiness.
• Maintain the Site Master File to be in a continual state of accuracy and inspection readiness.
• Support the delivery of New Employee Onboard Training.
• Oversee Quality Culture and Data Integrity initiatives and awareness across the site.
• Internally escalate significant quality incidents, primarily in regards to critical observations from audits by following the escalation and management notification process at the site. 
• Responsible to manage escalations for critical observations and to mitigate risk by working with all impacted departments.
• Attend customer meetings as the Compliance representative to provide guidance and strategic approach as required.
• Maintain SOPs in alignment with regulatory requirements, global and corporate requirements.
• Collect, analyze, trend and report out compliance metrics.

• 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 – 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’s degree in science
• Knowledge, Skills and Abilities

• Strong working knowledge of GMP, cGMP, HPFBI and FDA requirements 
• Sterile manufacturing experience within quality or production

• Demonstrated analytical and critical thinking
• Strong computer skills, organizational, interpersonal and communication skills
• Demonstrated interpersonal skills and relationship building
• Proven experience in delegation, coaching and developing direct reports
• Proven ability to manage multiple projects at the same time
• Strong written and oral communication skills

• Experience
  • Minimum 7 years experience in Compliance or Quality Assurance within a pharmaceutical manufacturing environment
  • Minimum of 2 years lead auditor experience within a pharmaceutical manufacturing environment
  • Experience in Pharmaceutical Sterile Manufacturing an asset