Title:
Senior Manager, Quality Operations
Company:
Ipsen Biopharmaceuticals Canada Inc.
Job Description:
Summary / purpose of the position
The Senior Manager, Quality Operations is primarily responsible for the overall management of Ipsen Canada’s Quality Management System to ensure compliance of GxP activities with the Canadian Drug and Medical Device regulations as well as Ipsen local and global policies and procedures. This role is responsible for establishing and maintaining relationships with manufacturing and distribution channels, providing quality and technical support, acting as the local lead for both internal and external audits, and managing all Drug Establishment Licensing activities. This role will also provide technical assistance, leadership, and support for special projects and teams as assigned.
Main responsibilities / Job expectations
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Establish and maintain Ipsen Canada’s Quality Management System to ensure compliance with all regulatory requirements, company policies and procedures.
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Supervise local product release activities and documentation review for accuracy and GxP compliance with registered licenses to ensure product release is completed in a timely manner.
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Manage all product complaints, change controls, deviations and CAPAs for Canadian distributed commercial products, ensuring that non-conformances and other reportable events are recorded, tracked and trends are analyzed.
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Establish and manage a comprehensive training program covering GxP activities for all Canadian employees.
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Lead activities to maintain Ipsen Canada’s Drug Establishment License for all applicable manufacturing, packaging/labelling and testing sites.
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Host and/or coordinate regulatory inspections and self-inspections/audits (in collaboration with local and Global GxP functions as needed).
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Maintain local SOPs, working instructions, policies and the GxP documentation archiving process across all relevant areas in accordance with Global Ipsen policies and local regulatory requirements.
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Support the Annual Product Quality Review process and maintenance of the stability program.
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Act as the main Quality contact to support warehouse quality systems and activities in conjunction with local warehouse and distribution partner(s).
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Conduct local supplier assessment and oversee maintenance of Quality Agreements.
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Manage product recovery and/or recall activities in Canada.
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Establish and maintain close communications and good working relationships with Health Canada, internal cross-functional partners and global colleagues.
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Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GMP/GDP/GCP/GVP regulations.
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Other Quality Operations and Regulatory Affairs duties, as required, to ensure ongoing compliance with Canadian requirements and the achievement of applicable goals and objectives.
Knowledge, abilities & experience:
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B.Sc. in Life Science or relevant scientific field (e.g., pharmacology, toxicology, chemistry).
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Approximately 7+ years in a pharmaceutical Quality Operations/Regulatory Affairs/Compliance role.
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Strong understanding of Health Canada’s GMP/GxP requirements.
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Excellent organizational and project management skills.
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Strong computer literacy and computer skills including Word, Excel, PowerPoint and Adobe Acrobat
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Knowledge of the use of eCTD software for preparing and filing submissions.
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Experience in writing and implementing compliance policies, procedures and quality systems is essential.
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Management training and proven ability to lead others to work together.
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Strong leadership skills and ability to work successfully in a cross-functional environment.
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Excellent interpersonal, written, verbal and presentation skills.
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Ability to balance short and long-term goals.
Key Technical Competencies Required
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Understanding of GMP and Canadian Regulatory requirements, including interpretation of the Food & Drugs Act and Regulations, relevant policies and guidelines.
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Scans the scientific, regulatory and business environments for current best practices, guidelines and approaches.
Ipsen Biopharmaceuticals Canada Inc. welcomes and encourages applications from people with disabilities. Accommodation is available on request for candidates taking part in all aspects of the selection process.
Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.
