Quality Manager, Commercial Quality

See Yourself at Telix

The Quality Manager will provide leadership and oversight for key compliance requirements, including training, metrics, recalls, complaints, deviations, change control, and annual quality product reviews. This role will monitor and update Pharmaceutical Quality Systems (PQS) in manufacturing, ensuring Master Control is maintained and key SOP revisions are completed. The Quality Manager will also oversee Quality Assurance Agreements (QAAs) with partners, manage changes with third-party vendors, and serve as the key point of contact for third-party distributors, manufacturers, and packagers, ensuring that products and services meet established standards of quality, reliability, and performance. This role assures compliance with regulatory and customer requirements, and drives continuous improvement across the organization.

In addition, this role will lead and oversee special quality improvement projects across the organization. This role will be responsible for managing the QA team, coordinating cross-functional improvement initiatives, and ensuring compliance with industry standards and regulatory requirements. The QA Manager will play a key role in driving a culture of continuous improvement and operational excellence.

Key Accountabilities:

• Good Manufacturing Practices (GMP)
  • Provide leadership and oversight for key compliance requirements (e.g., training, metrics, recalls, complaints, deviations, change control, annual quality product review)
• Pharmaceutical Quality Systems in Manufacturing
  • Monitor updates and training for Master Control
  • Assign key updates for SOP revisions, updates, etc. and monitors completion to approval
  • Approve key Quality documents
  • Executes key improvement projects to clean up, update, and maintain Master Control for commercial products
  • Key point of contact for key third-party distributors, manufacturers, and packagers
• Quality Assurance
  • Coordinate with key Manufacturing and Regulatory counterparts to address Quality issues
  • Review and approve Quality documents (e.g., MBRs, CC, deviations, validation reports, specification changes)
  • Lead implementation on key Quality improvements (e.g., mock recall, batch release process, quality plan)
• Regulatory Compliance
  • Lead inspection readiness efforts
  • Work with area management to develop key processes for front and back-room requirements
  • Coordinate recall and mock recall processes and provide training to staff
• Documentation and Record-Keeping
  • Monitor and develop key metrics to assure all Quality documentation and record keeping is managed in the PQS
  • Lead continuous improvement projects for PQS
• Special Quality Projects
  • Identify, plan, and execute special quality improvement projects, working cross-functionally with departments such as Operations, Engineering, and Regulatory.
  • Analyze data and quality metrics to identify areas for improvement and implement corrective and preventive actions (CAPAs).
  • Develop and implement project plans, timelines, and resource allocation for special QA initiatives.
  • Drive process optimization initiatives to improve product reliability, reduce defects, and increase customer satisfaction.
  • Prepare reports and presentations for senior leadership on project outcomes, KPIs, and quality trends.

Education and Experience:

• Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Biology, or related field required. Advanced degree preferred.
• 7+ years of experience in a quality assurance role in Pharmaceutical industry or the life sciences industry; 2 years of leadership experience
• Knowledge of regulatory requirements and standards within the life sciences industry
• Strong understanding of GMP guidelines and their application in commercial quality
• Knowledge of GDP requirements for the distribution of pharmaceutical products
• Familiarity with FDA regulations and guidelines relevant to commercial quality in life sciences
• Understanding of international regulatory standards such as EMA, ICH, and other relevant regulatory bodies
• Six Sigma Experience preferred

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills