Supervisor Compliance

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:

Supervise the activities of the Compliance Team to support timely delivery of our commitments to customers and patients. Ensure effectiveness of the Site’s Self-Inspection and Audit Readiness programs. Organize and lead Regulatory Inspections, Corporate Audits, and Client Audits. Apply regulatory expertise and intelligence to day-to-day operations, oversee regulatory submissions and licensing, maintain the Vendor Management program, and the establishment and maintenance of Quality Agreements. Ensure documents conform to all corporate policies, Patheon Standard Operating Procedure (SOPs), client requirements and Good Manufacturing Practices.

Essential Functions:

1. Establish objectives for the Compliance team to align with site objectives; maintain a strong team and provide effective communication across functional groups to successfully deliver on commitments.
2. Manage Audit Readiness to ensure the site is inspection ready at all times by use of the Risk Management program.
3. Lead the audit team that performs Internal Audits, and hosts Corporate Audits, Client Audits, and Regulatory Inspections.
4. Manage the Self-Inspection program and oversee functional walk-throughs to ensure compliance to corporate directives, site procedures, and regulatory requirements.
5. Manage Regulatory Inspections, Corporate Audits, and Client Audits. Interact with auditors and represent the site during inspections to ensure information is provided in a timely, accurate and complete manner.
6. Oversee and assist in audit response development and review responses to audit findings for completeness and effectiveness.
7. Responsible for timely and effective execution of audit commitments. Interact with SMEs in all functional areas to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.
8. Maintain awareness of regulatory intelligence in support of gap identification and mitigation to ensure compliance.
9. Oversee regulatory submissions and licensing activities.
10. Support the management of the Vendor Management program.
11. Support the management of the Quality Agreement Program.
12. Collect, analyze, trend, and report out compliance metrics.
13. Attend client meetings as Compliance representative to provide guidance and strategic approach.
14. Perform other duties and support special projects as assigned.
15. Promote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures.
16. Select, develop, and evaluate colleagues to ensure the efficient operation of the function. Work with and advise colleagues on administrative policies and procedures.

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science (BSc) in Chemistry, Biology, Pharmacy, Engineering, or related field.

Experience:

Minimum 7 years’ experience in Compliance or Quality Assurance within the pharmaceutical industry.

Minimum 2 years audit experience.

Lead Auditor Certification preferred.

Previous supervisory and/or leadership experience.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, and Abilities:

Thorough knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures. Possess a highly developed quality, regulatory and production approach with an appreciation for client service and the contract manufacturing industry. Proven leadership and problem solving abilities. Ability to prioritize multiple project deliverables. Ability to motivate and influence. Organized and detail oriented. Excellent written and verbal communication skills. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be always client and patient conscious. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.