Compliance Lead

WHO WE ARE:

At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.

For more than 30 years CPL has partnered with the world's leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.

We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee's assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

PURPOSE OF THE POSITION:

Responsible for Internal Audits, Client Audits, and Regulatory Inspections. Lead and ensure the effectiveness of the Internal Audit Program and Inspection Readiness Program. Monitor Regulatory Intelligence for emerging trends and action risk mitigation through the Inspection Readiness Program. Apply compliance knowledge to daily operations to ensure compliance with regulatory requirements and CPL procedures. Execute Regulatory and Licencing activities. Deliver commitments to customers on time and in quality.

RESPONSIBILITIES:

• Lead the CPL Inspection Readiness Program, with the use of Risk Management Principles, to ensure CPL is always ready for inspection.
• Lead and manage Customer Audits and Regulatory Inspections (prepare, host, and facilitate) in alignment with requirements and industry best practice.
• Lead and perform Internal Audits in a manner that supports continual inspection readiness.
• Manage the annual schedules for Internal Audits, Customer Audits, and Regulatory Inspections to ensure compliance with requirements (regulatory, customer, and procedural requirements).
• Manage the audit response process for Internal Audits, Customer Audits, and Regulatory Inspections with the involvement of cross functional departments to ensure responses address the specific issue, the systemic process, and are timely.
• Oversee the creation of audit / inspection CAPAs to ensure they adhere to industry best practice, appropriate effectiveness checks are defined, and impact to business is minimized by assessing for existing open CAPAs and their associated timelines to reduce conflicting priorities and ensure due dates are realistically achievable.
• Collaborate effectively with cross functional teams including Production, Facilities, Quality, QC, Engineering, Product Development, and Project Managers to achieve Audit and Inspection objectives.
• Develop and maintain SOPs related to Internal Audits, Customer Audits, and Regulatory Inspections to ensure alignment with regulatory requirements and industry best practice.
• Collect, analyze, trend, and report audit and inspection metrics with action plans as required.
• Maintain awareness of regulatory intelligence in support of gap identification and risk mitigation.
• Perform Regulatory and Licencing activities in compliance with requirements and perform GMP Gap Analysis when required (i.e. in support of licence requirements).
• Perform change control impact assessments to evaluate the compliance impact of proposed changes.
• Prepare and respond to Customer Questionnaires in a timely and accurate manner.
• Prepare content and attend Customer meetings as Compliance representative when required, particularly for proactive issue resolution.
• Perform and support Investigations and CAPAs as required.
• Ensure assigned projects are planned and executed on time, with timely report outs on status and proactive escalation for risk mitigation.
• Perform as the delegate for the Compliance Manager and Senior Director Compliance as required.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor of Science (BSc) in a Scientific discipline, or a College Diploma in a Scientific discipline in combination with significant experience (minimum of 10 years) in Quality within the Pharmaceutical Industry.
• Minimum of five (5) years of auditing experience within the pharmaceutical industry.
• Minimum of seven (7) years of experience in Quality within the pharmaceutical industry.
• Strong working knowledge of current Good Manufacturing Practices; and Health Canada, FDA, EMEA regulatory requirements, as well as the Health Canada Office of Controlled Substances regulatory requirements.
• Strong verbal and written communication skills to support audit facilitation; inclusive of technical writing for generation of Audit Reports (written observations and written responses).
• Effective leadership skills with a proven ability to influence without authority, combined with confidence in decision making.
• Excellent organizational skills coupled with time management skills to successfully manage tasks and on time delivery.
• Exceptional problem-solving / conflict resolution capabilities and communication skills to liaise across departments, levels of the organization, with Customers and Regulatory Inspectors.
• High attention to details in documents' reviewing for accuracy and compliance.
• Flexible with the ability to adapt, respond quickly and manage changes in a fast-paced environment.
• Working knowledge of computer systems such as TrackWise, LIMS, SAP, Microsoft Office 365, etc.
• Auditing certification issued by ASQ or equivalent bodies is an asset but not required.
• Previous supervisory, project management, and customer experience is an asset, but not required.
• Demonstrated competencies in CPL's core values.

PHYSICAL DEMANDS/WORKING CONDITIONS:

• Flexibility in hours of work to address Audit and Inspection needs that may arise outside of the normal workday.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us.

We thank all applicants for their expression of interest; however, only those selected for an interview will be contacted. No phone calls or agencies please.