Manager Operations Safety and Compliance

3 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

**Summary**:
Manage the activities of the Operations Team to meet quality standards (e.g. full cGMP, health, safety and environmental compliance). Ensure effectiveness of the Self-Inspection and Audit Readiness programs. Participate in Regulatory Inspections, Corporate Audits, and Client Audits. Ensure Operations compliance with EHS regional regulations and corporate EHS requirements.

**Essential Functions**:

- Establish objectives for the Operations team to align with site Safety and Compliance objectives; effective communication to drive improvements across functional groups to successfully deliver on commitments.
- Manage Audit Readiness to ensure inspection readiness at all times.
- Participate in Internal Audits, 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.
- Oversee and assist in audit response development and review responses to audit findings for completeness and effectiveness.
- Identify continuous improvement opportunities to improve overall EHS performance across Operations.
- Support and actively participate in incident investigations related to Safety and Compliance.
- Ensure department risk assessments and EHS observations are developed and scheduled, and audits are performed according to plan.
- Instill a culture of professionalism and respect for co-workers, clients and the products with which we work.
- Promote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures.
- Select, develop, and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.
- Perform other duties and support special projects as assigned.

**REQUIRED QUALIFICATIONS**

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

**Experience**:
5+ years’ experience within the pharmaceutical industry.

Previous experience in EHS, Compliance and/or Operations 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 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.

**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.

**Disclaimer**:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

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