Quality Assurance Manager - Batch Release

at  AtomVie Global Radiopharma Inc

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment 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.

REQUIREMENTS

• BSc or equivalent in Pharmacy, Engineering, Chemistry, Microbiology or a related field.
• 10+ years of relevant experience in the pharmaceutical, radiopharmaceutical or biopharmaceutical industry.
• Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations as they pertain to sterile products; knowledge of radiotherapeutics is an asset.
• Minimum of 3 years in a management role with demonstrated leadership and behavioural competencies.

AtomVie Offers

• Group Health & Dental Benefits (from day 1)
• RRSP Matching Program
• Perkopolis
• Employee Assistance and Wellness Programs
• Parking Allowance

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization

ABOUT THE ROLE

The Quality Assurance Manager - Batch Release oversees compliance with Good Manufacturing Practices (GMP) in relation to material and product release activities. These activities encompass the development and production of both clinical and commercial products, from the introduction of new programs to the routine manufacturing phase at AtomVie’s facilities. As a highly seasoned Quality professional with an exceptional ability to build relationships, lead, and inspire you will oversee a team of skilled QA professionals responsible for material release, batch release, batch close-out, and other associated activities.

WHAT YOU WILL DO

• Ensure compliance with material and batch release activities for commercial and clinical production using industry leading best practices.
• Manage a team of QA professionals performing material release, batch release, batch close-out, and other associated activities
• Provide technical expertise to ensure timely and appropriate decision making and reporting related to quality issues in support of manufacturing activities
• Communicates quality and compliance issues to all relevant stakeholders in a timely manner
• Ensures AtomVie is inspection ready and is operating within a compliant quality environment
• Ensures compliance with Health, Safety and Environment protection rules, with engagement of all associates to apply the policies, procedures and regulations applicable to their work
• Using a continuous improvement mindset, trend key deliverables, identify and implement streamlined processes and procedures ensuring compliance in alignment with current industry expectations
• Mentor, coach and support the development of the team of direct reports
• Work closely with other departmental managers to ensure employees are working in compliance with internal policies and procedures, external client expectations, and GMPs
• Work collaboratively to ensure AtomVie’s quality management system remains in compliance with regulatory requirements and meets the needs of all stakeholders.
• Work alongside Manufacturing and Quality Operations to troubleshooting and develop action plans for any decision-making on batch release
• Review, assess, and approve controlled documents change controls, CAPAs, investigations, non-conformances, product/service complaints as required.
• Supports and participates as SME in on-site audits by regulatory authorities and clients ensuring audit readiness
• Serve as the Quality Assurance representative on cross-functional teams to support transition of manufacturing processes from qualification/validation to routine production
• Lead the Annual Product Quality Review process.
• Complete all other duties, as required.

WHAT YOU BRING TO THE ROLE

• Adaptability with a desire for working in a fast-paced, growth-oriented environment.
• Ability to work with a sense of urgency, prioritize work, meet objective/deadlines with strong organizational skills.
• Strong project management skills with the ability to work independently and within a team.
• Capacity to drive improvement projects and deliver high-quality work even under pressure.
• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.
• Solves problems with evidence of good judgment and decision-making skills.
• Flexibility in work schedule to support a 24/7 production environment.
• Strong client-facing and teamwork skills.