Senior Manager, Site Quality Assurance

See Yourself at Telix

As the Senior Quality Manager, Site Quality Assurance, it is expected that the candidate has the Quality Assurance responsibility and leadership related to IsoTherapeutics Group (ITG) Site’s activities. Coordinate and assist in the active management and implementation of the CMO products as directed, including aspects of quality requirements. Actively participating in and supporting the quality needs of the programs across the organisation’s jurisdictions. The role is on-site, located in Angleton Texas.

Key Accountabilities:

• Lead cross functional teams including quality systems, training and operations QA.
• Understand and adhere to GMP Policies for the major health authorities.
• Prepare, review and approve documents within ITG Quality Management System (QMS).
• Lead QMS improvement projects, including but not limited to, eQMS integration, Improvements due to regulatory guidance changes, etc.
• Investigate and resolve products and process problems related to quality issues.
• Ensure CAPA’s and quality issues are properly documented, and corrective actions taken.
• Participate in investigations of customer complaints; working with subcontractors and operations to resolution.
• Collaborate with production / manufacturing teams to monitor all work according to requirements under ITG quality system. Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with ITG quality and regulatory requirements.
• Participate in the preparation of the manufacturing and quality sections for regulatory submissions.
• Participate in communication with the regulatory agencies as needed.
• Identify required system and process gaps within the ITG QMS and facilitate corrective and preventative actions as required.
• Personal development – maintain standard knowledge and make recommendations for professional development and training.

Education and Experience:

• Bachelor’s degree required. Orientation in pharmacy, biochemistry or science filed is highly preferred.
• 9+ years’ of experience in pharmaceutical or biotechnology manufacturing environment with Good Manufacturing Practices (GMP) required.
• Experience working in close support with R&D, Operations and Quality required.
• Experience working in radiopharmaceuticals or radionuclide(s) manufacturing (preferred).
• Previous experience writing and reviewing with understanding SOPs and specifications.
• People management experience (direct reports) highly preferred.
• Strong written and oral communication skills required.
• Technical understanding of manufacturing, quality and regulatory requirements.

Key Capabilities:

• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals,
• 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,
• 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.