[Hiring] Director, Commercial Product Quality @AMER

Role Description

The Director, Commercial Product Quality plays a pivotal role in ensuring the highest standards of product quality and compliance within our commercial manufacturing operations. The scope includes intermediates, Bulk Drug or API, Drug Product, Packaging and Labeling, as well as Commercial Distribution. This leadership position requires a seasoned professional with a deep understanding of quality assurance, regulatory compliance, and a proven track record of success in the pharmaceutical or biotechnology industry. The successful candidate will be responsible for overseeing and enhancing quality management systems, driving continuous improvement initiatives, and collaborating with cross-functional teams to maintain and improve the quality of our commercial products.

Key Accountabilities:

• Good Manufacturing Practices (GMP):
  • Demonstrate expert understanding of ICH and GMP standards from larger health authorities worldwide, and guidelines governing the production of radiopharmaceuticals and medical devices.
  • Educates business partners on fit-for-purpose GxP requirements, ensuring a comprehensive understanding across teams.
• Pharmaceutical Quality Systems in Manufacturing:
  • Ensures manufacturing processes meet established quality standards through a formalized system.
  • Leads the department’s strategic quality improvement.
  • Ensures that PQS systems are aligned across sites.
• Quality Assurance and Control:
  • Utilize expertise to ensure that products meet quality standards, both during production and prior to release.
  • Collaborate with matrix teams on pipeline products, addressing Quality needs at the earliest stages.
  • Establishes an analytical framework for Quality problem-solving.
  • Ensures that analytical problem-solving skills are continuously developed within the team.
• Regulatory Compliance:
  • Demonstrate in-depth knowledge of regulatory requirements in the life sciences industry and assure department alignment with current regulatory expectations.
  • Leads companywide initiatives to improve continuous compliance.
  • Develops the overall regulatory compliance strategy.
• Documentation and Record-Keeping:
  • Ensures that documentation practices align with authority expectations within the department and with contract partners.
  • Collaborate with cross-functional business partners and third-party suppliers to ensure all required documentation is captured within Telix, meeting fit-for-purpose criteria.

Qualifications

• Bachelor’s degree in a relevant scientific or engineering field required; advanced degree preferred.
• 12+ years of experience in quality within the pharmaceutical or biotechnology industry.
• 8+ years of leading people in the pharmaceutical or biotechnology industry.
• Proven experience in driving the continuous improvement of pharmaceutical quality systems in a regulated environment.
• Drive strong team understanding of global regulatory requirements, including FDA and EMA regulations.
• Excellent leadership and communication skills with the ability to influence and collaborate across departments.
• Demonstrated success in driving continuous improvement initiatives and achieving measurable results.

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.
• Adaptability: Comfortable working in a dynamic, global environment across multiple time zones, 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.
• Creativity and innovation: Possess a willingness to think outside the box, take initiative 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.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Ability to work under pressure and with tight timelines; 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.