Director, Quality Assurance

AtomVie Global Radiopharma•Hamilton, ON

1d•Hybrid

About The Position

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. About the Role Reporting to the VP, Quality, the Quality Assurance Director will lead the quality assurance program for innovative radiopharmaceutical products manufactured at AtomVie. The incumbent will be responsible for maintaining and further developing quality systems that support the rapid growth of AtomVie’s business related to contract development and manufacturing operations. They will deliver functional expertise to AtomVie while working in partnership with key functional areas, including Product Development, Operations, Regulatory Affairs and Manufacturing. The Quality Assurance Director will be responsible for quality assurance oversight of drug development through commercialization, including the manufacture of clinical and commercial products with a strong focus on Quality Systems and Batch release. The role will provide leadership and collaborate with all relevant functional areas to ensure compliance with applicable cGMP regulations and any additional applicable regulatory requirements. The Quality Assurance Director 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. Location: AtomVie Global Radiopharma Inc., Hamilton ON (Hybrid)

Requirements

BSc. /MSc. /PhD. in a relevant scientific discipline with 15 years' QA experience in the pharmaceutical/biotech industry with at least 5+ years at a managerial level with direct reports.
Knowledge of maintaining a cGMP pharmaceutical manufacturing operation according to FDA, Health Canada and EMA requirements for investigational and commercial products.
Experience in a sterile manufacturing environment is a strong asset in this role.
Experience in smaller, earlier stage companies developing quality systems from the ground up.
Competent in achieving market authorization of new products, including the management of pre-approval inspections.
Hands on knowledge of electronic quality management systems is required and experience in selection and implementation of a system would be an asset.

Nice To Haves

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.

Responsibilities

Responsible for all aspects of Quality Assurance, driving continuous improvement initiatives and providing oversight to ensure full compliance of sterile manufacturing operations with regulations and guidelines set forth by Heath Canada, FDA and EMA and any applicable production standards.
Achieves Quality Assurance operational objectives by monitoring and assigning day-to-day activities, identifying and addressing gaps and problems; completing audits; implementing change and providing regular feedback to management and stakeholders regarding system performance.
Serves as the Quality Assurance liaison with external clients for projects at all stages of clinical development and commercialization.
Hosts regulatory and client audits and assumes responsibility for ensuring that internal stakeholders are included in establishing and implementing corrective actions in a timely manner.
In relationship with the VP, Quality develops enhances and implements effective, robust quality management system (QMS) processes and methods in alignment with FDA, HC, EMA, ICH, QSR and other requirements.
Champions a culture of quality within the organization and identifies and proactively corrects compliance gaps and risks where needed.
Implements changes and provides regular feedback to employees and stakeholders regarding quality system performance.
Maintain current knowledge of regulations and take responsibility for Quality Assurance staff training.