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: 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. 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. Interact with 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 Vendor Management program. 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. Promote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures. 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
