Supervisor Compliance

3 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**How will you make an impact?**

**What you will do**:

- Establish objectives for the Compliance team to align with site objectives; maintain a high performing team and provide effective communication across functional groups to successfully deliver on commitments.
- Manage Audit Readiness to ensure the site is inspection ready at all times by use of the Risk Management program.
- Lead the audit team that performs Internal Audits, and hosts Corporate Audits, Client Audits, and Regulatory Inspections.
- Manage the Self-Inspection program and oversee functional walk-throughs to ensure compliance to corporate directives, site procedures, and regulatory requirements.
- Manage Regulatory Inspections, Corporate Audits, and Client Audits. Interface with the auditors and represent the site during inspections to ensure information is provided in a timely, accurate and complete manner.
- Oversee and assist in audit response development and review responses to audit findings for completeness and effectiveness.
- 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.
- Maintain awareness of regulatory intelligence in support of gap identification and mitigation to ensure compliance.
- Oversee regulatory submissions and licensing activities.
- Support the management of the Quality Agreement Program.
- Collect, analyze, trend, and report out compliance metrics.
- Attend client meetings as Compliance representative to provide guidance and strategic approach.
- Perform other duties and support special projects as assigned.

**How will you get here?**

**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.

At least 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**:

- Sound knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.
- Possess a highly developed quality, regulatory and production mindset 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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