VP Quality

AtomVie Global Radiopharma•Hamilton, ON

19h•Hybrid

About The Position

The Vice President Quality is responsible for AtomVie Global Radiopharma (AtomVie)'s product quality and safety upholding AtomVie’s compliance with all regulatory requirements. The Vice President Quality 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 Vice President Quality will develop, implement and maintain quality standards across the company in support of clinical and commercial manufacturing of drug products according to the highest standards of quality, regulatory and safety guidelines and criteria globally. Ensuring just-in-time delivery schedules, the position oversees the Quality Assurance, Quality Control, Sterility Assurance, Validation, and Analytical Development functions. The position also provides leadership and functional expertise to AtomVie while working in partnership with key functional areas, including Operations, Regulatory Affairs, Business Development, Human Resources and IT & Administration. The VP Quality will be accountable for all quality related aspects of the expansion plan to the new facility, and the transition plan and execution, as well as maintaining the GMP activities in the current location, including decommissioning of the current facility. The Vice President Quality will play a key role in driving operational and cultural change towards quality assurance across the organization, helping establish effective, commercial-ready, world-class pharmaceutical GMP operations and supporting the transition from clinical to commercial GMP activities.

Requirements

Strong experience in Health Canada, FDA and EU GMP regulations, requirements, and audit processes, with specific knowledge of the regulations as they pertain to sterile products.
Experience in successfully leading GMP quality cultural change across an organization.
Adaptable and a desire for working in a fast-paced, growth-oriented environment.
Strong coaching and leadership skills exemplified by a successful track record of developing teams and individuals.
Outstanding project planning, organization, communication (verbal and written) and relationship skills (internal and external)
Proficiency in the English language both written and oral and excellent communication skills; detail oriented.
Flexibility in schedule to support a 24/7 operational environment.
BSc. / MSc. / PhD. In a relevant scientific discipline
Minimum of 15 years of pharmaceutical QA experience in an FDA/ Health Canada/ EMA regulated - industry is a must. Pharmaceutical biotech experience is an advantage.
Minimum of 10 years' experience in Pharmaceutical QA management cross-functional teams including QC operation is a must.
Hands-on experience in developing and executing a companywide GMP quality strategy.
Experience in leading inspections and regulatory audits (HC/FDA/EMA), and achieving market authorization of new products, including the management of pre-approval inspections
Experience in a sterile manufacturing environment is a must.
Experience in facility design and validation is a must.
Experience in Regulatory Affairs is an asset.

Nice To Haves

Pharmaceutical biotech experience is an advantage.
Experience in smaller, earlier stage companies is an advantage.
Experience in Regulatory Affairs is an asset.

Responsibilities

Directs, develops, and mentors a team of professionals for all aspects of quality and compliance at AtomVie while creating a development plan for staff retention and engagement.
Drive, maintain and improve the quality culture across the company through a collaborative approach based on education and training.
Provides oversight to ensure full compliance of sterile drug manufacturing in accordance with cGMP regulations and guidelines set forth by Health Canada, FDA, EMA, and industry best practices.
Leads regulatory and client audits and assumes responsibility for responding to audit reports and implementing corrective actions in a timely manner.
Ensures the accuracy and compliance of data and information provided to auditing / regulatory bodies, clients, management, and other stakeholders.
Ensures the functions under his/her oversight are staffed and scheduled to enable just-in-time product release.
Drives teams to ensure the timely implementation and close out of all quality systems and documentation supporting new processes, changes and routine manufacturing.
Continually drives a culture of quality throughout the organization and provides an overall quality strategy to the leadership team.
Leads the quality continuous improvement process, including monitoring and reporting the quality measures and KPIs/metrics and progress on achieving the quality objectives. Oversees the performance of periodic meetings to review all key performance indicators and trends.
Develops and implements a regular lifecycle review of the facility design, qualification, and operation against the GMP requirements, including the GMP quality systems and tools.
Develops programs for the audit and qualification of suppliers and vendors to ensure meeting the quality and GMP standards of AtomVie.
Leads and implements a robust document management system (DMS), data integrity and retention policies, Quality risks management and governance program (QRG), and quality review and escalation process.
Supports the regulatory team to successfully complete, submit, and respond to regulatory affairs and submittals requirements.
Ensures planning budgeting, and execution of the Opex/Capex needs of the quality department.
Develops and implements effective, robust quality management system (QMS) processes and methods in alignment with FDA, HC, EMA and other regulatory bodies requirements, through managing and controlling deviations, CAPAs, change controls, Product Quality Reviews (PQR), QC and Micro inspection programs, complaints management, and recalls management, internal audits.
Develops and sets goals for Quality department, and follows up on progress through monitoring, identifying and addressing gaps and problems.
New facility – staffing plans, overseeing facility commissioning, validation and qualification. Directing the Facility Delivery Team, making sure that all regulatory and quality compliance requirements in the new facility are identified, planned and budgeted, and that all tasks are being executed as planned, including ensuring the new facility will be PAI ready as per the expected timelines.
Develops and implements quality and compliance systems strategies and plans to enable AtomVie transition into commercial programs as a commercial manufacturing ready facility.
Establishes and monitors quality agreements with clients. Ensures compliance with Health, Safety and Environment requirements.