Senior Manager, Quality Assurance/Quality Systems

Position Summary:

The Sr Quality Assurance, Quality System & Compliance Manager is responsible for the development and direct supervision of both the Departments of Quality Assurance and Quality System Compliance and ensures that the Company’s Quality Program’s objectives are achieved. Reviews regulatory submissions to Health Canada, USA FDA, EU, and other markets, provides guidance on submission classification and requirements for major changes. Oversees the risk assessment workflow process, provides responses as applicable for regulatory and internal audits; reviews/approves technical documents, including validation reports and R&D characterization and stability report. Responsible for managing all aspects (i.e. quality systems, documentation, laboratory operations, compliance, training, staffing and budgetary needs, etc.) of a Quality Assurance /Quality Systems & Compliance Operations (QA/QS&C) business unit within QA Supply Chain, Product Quality Management, or Compliance, Audits, and Systems.

Reports to: Sr Quality Director

Key Duties and Responsibilities

• Provide advice and strategic direction in the fields of quality, system improvement and development of the teams' capacity
• Manage Audit CAPA system, Maintain Site Master File and Manage Quality Agreement system
• Interface with various groups to ensure that content in complex technical submissions and information requests to Health Canada, FDA and other regulatory agencies is accurate and complete.
• Provide guidance as well as consult with manufacturing and internal regulatory departments on GXP matters
• Oversee supplier management system and supports the raw material qualification program
• Use expertise and sound judgment to make independent decisions within defined areas of responsibility
• Participate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility
• Review and approve technical protocols and reports including stability, characterization and validation studies
• May investigate and initiate corrective action places for quality related issues
• Plan and analyze workflow, delegate and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget
• Provide effective leadership to employees in Quality assurance operations
• Identify, drive and implement process and system improvements
• Directly supervise two (2) Department Managers and supervises activities performed by QA teams
• Manage all aspects of a Quality Assurance and Quality Systems & Compliance Operations (QA/QS&C) Operations business unit (quality systems, documentation, laboratory operations, overall compliance, oversee department budget, employee relations
• Participate in the development of annual budget expectations for the Regulatory Compliance department
• Manage the Risk Assessment System process
• Practice high level of facilitations skills to reach consensus and works toward solutions
• Evaluate and assess change controls to determine applicable requirements and assist in determining regulatory reporting classification and requirements
• Release approved regulatory changes in SAP for implementation in manufacturing
• Communicate with cross functional departments and support groups to improve departmental performance and efficiency
• Manage the Regulatory Compliance operations and systems (cGMP regulatory, internal, and external audits including writing observation responses)
• Provides support, direction and coaching to subordinate employees in the areas of the Regulatory Compliance department.
• May review and revise Standard Operating Procedures and generate reports
• Provide guidance and scientific/technical advice regarding validations and validation deviations as needed
• Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards
• Provide regular updates to senior management and corporate

Additional responsibilities: In addition to the duties described above the Sr Manager, Quality Assurance and Quality Systems & Compliance may also perform the following duties based upon the business unit to which he/she is assigned:

• Quality Operations Supply Chain: Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations and write reports. Author SOPs and other laboratory documents. Collaborate with production and PQM on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects. Serve as system administrator and SME for various laboratory information systems and applications as required

• Quality Operations Compliance, Audits, and Systems: Lead/participate in internal and external compliance audits. Lead/participate in supplier quality audits. Prepare, review, and/or approve validation and/or engineering documents. Anticipate/ lead internal compliance audits, audits of suppliers/contractors. Perform sampling/testing of raw materials. Collect and control stability program samples, review and analyze data, prepare and review reports. Perform validation studies, prepare/review/approve validation documents. Participate in failure investigations, preparation/review of reports. Author, edit, and/or publish SOPs and other documents. Collect, store, record samples and test results for follow-up and developmental stability program. Collect and test samples for incoming raw materials and/or materials clearance testing. Review and approve reports and documentation prepared by other employees. Plan, schedule and execute routine and directed internal audits and follow-up on observations from previous audits. Revise, negotiate, and complete Quality Agreements, Manufacturing Agreements and Confidentiality Agreements with suppliers, customers and distributors.

• Quality Operations Product Quality Management: Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, LIMS, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, stability studies, ETPs, and Regulatory submissions.

Qualifications required:

• Strong problem resolutions skills. Must be agile and able to easily adapt to change. In-depth knowledge of Health Canada and FDA regulation.
• Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
• Excellent communication skills (written and verbal French and English ) and demonstrated listening skills. Extensive working knowledge of domestic (i.e. Health Canada) and applicable foreign regulatory agency requirements/guidelines (i.e. Food and Drug Administration)
• PHD in a Life Sciences or relevant degree with minimum of 8 years relevant experience. MSc in a Life Sciences or relevant degree with minimum of 12 years relevant experience. BSc in a Life Sciences or relevant degree with minimum of 15 years relevant experience.