Sr Manager Compliance

at  Thermo Fisher Scientific

SUMMARY:

Provide direction and management of the Compliance Program and associated activities. Ensure Compliance/Quality Systems in place are periodically audited and assessed to ensure that Patheon meets current and anticipated Federal Health Products and Food Branch Inspectorate (HPFBI)/ United States Food and Drug Administration (FDA)/ European Union (EU)/ The National Health Surveillance Agency Brazil (ANVISA), etc., as well as Corporate and Customer Good Manufacturing Practices (GMP) requirements.

EDUCATION:

Bachelor of Science (B.Sc.) in Chemistry, Pharmacy or a science related to pharmaceutical analysis.
In order to meet regulatory compliance all hires, promotions, or transfers to this role are required to provide evidence of education equivalency should the incumbent have a degree outside of Canada.

EXPERIENCE:

Minimum 15 years’ experience in quality within the pharmaceutical industry
Minimum 8 years previous supervisory and/or leadership experience
Previous Project Management experience.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Exceptional cGMP, GLP and HPFBI/FDA compliance knowledge. 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. Knowledge of laboratory testing and equipment technologies an asset. Able to risk assess existing quality systems to ensure no gaps with corporate policies, SOPs and regulatory requirements. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Direct teams responsible for reporting and site governance of Quality Bowler (and associated metrics), Document Control, Training, Audits, Vendor Management, Regulatory & Licensing activities, Risk Management, Quality Management Review, Quality Systems (i.e., Deviation management, Change Control, APRs, etc.) including the Quality Project Leads (QPLs), and oversees the management of Controlled Substances at the Patheon WRO site.

• Ensure facility compliance systems are established as per FDA, HPFBI and other Regulatory Agency requirements through internal audits, strategy meetings, compliance meetings, etc.
• Ensure that the facility is always in pre-approval Inspection (PAI) readiness mode.
• Ensure Good Manufacturing Practices training program is meaningful and delivered in a timely manner to all Good Manufacturing Practices functional areas.
• Review metrics for Standard Operating Procedure (SOP) documentation control and evaluates allocation of resources to prevent backlogs.
• Assist with the vendor management program to meet compliance expectations for the Canadian Operations.
• Oversee coordination and performance of Quality Systems linked to Investigative, Change Control, and Corrective and Preventative Actions (CAPA) initiatives.
• Provide quarterly Investigation and CAPA evaluation within the Compliance department and ensures plan of actions and follow-ups to measure the effectiveness of the implemented actions.
• Evaluate, challenge, and implement quality improvements to processes across PDS, Commercial and Quality operations.
• Directs the site Investigation team for resolution of all Deviations and OOS activities. This also includes overseeing Complaint management and Incoming material investigations.
• Oversee management of controlled drugs at the site to meet office of controlled substances (OCS) requirements.
• Provide timely responses to client regulatory requests.
• Provide leadership, mentoring, coaching for direct reports and site.
• Manage departmental budget for proper staffing and expenses.
• Maintain a Regulatory Watch for all recent GMP regulatory updates for the site and global.
• Manage multiple small-medium projects and/or improvement initiatives.
• Direct Failure Mode and Effect Analysis (FMEAs) for site improvements associated with construction, expansion, site deviations, product deviations, complaints, and validation.
• Owns the Site Risk Management process and facilitates the monthly SLT risk review. This also results in the management of the corporate Risk Management database.
• Practice standard project reporting procedures to client and management. (i.e., minutes, agendas, etc.)
• Work with management to resolve project issues and resource constraints within the team.
• Perform periodic reviews on the sustainability of new and existing risk initiatives.
• Promote a safe working environment, reports potential hazards, and ensures all direct reports follow the 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.