Vp, Quality Jobs

VP, Quality

Hamilton, ON

Introduction

We are currently hiring a Vice President, Quality for our client based in Hamilton, Ontario. The Vice President of the Quality department will be responsible for the company's product quality and safety and for upholding the company's compliance with all regulatory requirements. The successful candidate will drive the quality culture and vision of the company to enable the roll-out of the company's strategic plan and future growth. By working with the CEO, the VP, Quality will develop, implement, and maintain quality standards across the company in support of clinical and commercial manufacturing of products according to the highest standards of quality, regulatory, and safety guidelines globally. This position oversees the Quality Assurance, Quality Control, Microbiology labs, Validation, and Analytical Development functions and provides leadership and functional expertise in partnership with key functional areas.

Responsibilities

• Support regulatory team in completing, submitting, and responding to regulatory affairs requirements.
• Foster a culture of quality throughout the organization and provide an overall quality strategy to the leadership team.
• Establish and monitor quality agreements with clients, ensuring compliance with Health, Safety, and Environment requirements.
• Ensure accuracy and compliance of data and information provided to auditing/regulatory bodies, clients, management, and stakeholders.
• Develop programs for supplier and vendor audit and qualification to meet AtomVie's quality and GMP standards.
• Implement robust document management, data integrity and retention policies, Quality risks management and governance program, and quality review and escalation process.
• Plan, budget, and execute Opex/Capex needs of the quality department.
• Set goals for the Quality department and monitor progress, identifying and addressing gaps and problems.
• Lead regulatory and client audits and respond to audit reports, implementing corrective actions in a timely manner.
• Develop and implement regular facility lifecycle reviews against GMP requirements, including quality systems and tools.
• Develop and implement effective quality management system (QMS) processes and methods in alignment with regulatory bodies' requirements, managing deviations, CAPAs, change controls, Product Quality Reviews (PQR), QC and Micro inspection programs, complaints management, and recalls management.
• Develop and implement quality and compliance systems strategies and plans for commercial manufacturing readiness.
• Drive timely implementation and close out of all quality systems and documentation supporting new processes, changes, and routine manufacturing.
• Lead the quality continuous improvement process, monitoring and reporting quality measures, KPIs/metrics, and progress on achieving quality objectives.
• Lead, develop, and mentor a team of professionals in all aspects of quality and compliance, creating a development plan for staff retention and engagement.
• Ensure just-in-time product release by staffing and scheduling functions under oversight.
• Ensure full compliance of sterile drug manufacturing with cGMP regulations and guidelines set forth by regulatory bodies.
• Oversee staffing plans, facility commissioning, validation, and qualification for the new facility, ensuring regulatory and quality compliance.

Requirements

• BSc./MSc./PhD. in a relevant scientific discipline.
• Experience in Regulatory Affairs is an asset.
• Experience in smaller, earlier stage companies is an advantage.
• Hands-on experience in developing and executing a companywide GMP quality strategy.
• Experience in a sterile manufacturing environment.
• Outstanding project planning, communication (verbal and written), and relationship skills.
• Minimum of 10 years' experience in Pharmaceutical QA management cross-functional teams, including QC operations.
• Experience in facility design and validation.
• Minimum of 15 years of pharmaceutical QA experience in an FDA/Health Canada/EMA regulated industry.
• Experience in leading inspections and regulatory audits (HC/FDA/EMA) and achieving market authorization of new products.

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About Us

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