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Senior Director, Quality and Compliance
2 months ago
As a key member of the AtomVie Global Radiopharma Inc. team, the Quality Assurance Director will play a critical role in ensuring the company's commitment to quality and compliance.
The successful candidate will be responsible for leading the quality assurance program for innovative radiopharmaceutical products manufactured at AtomVie, maintaining and further developing quality systems that support the rapid growth of the company's business related to contract development and manufacturing operations.
The Quality Assurance Director will provide leadership and collaborate with all relevant functional areas to ensure compliance with applicable GxP (GLP, GCP and GMP) regulations and any additional applicable regulatory requirements.
Key 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 Health 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 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.
- Establishes quality systems for the commissioning of new radiopharmaceutical production facilities and equipment.
- Maintain current knowledge of regulations and take responsibility for Quality Assurance staff training.
- Strong understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products.
- 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 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.
