CSL
Associate Director, Head of Batch Release
Seqirus USA - NC - Holly Springs · Director
Sponsorship not specifiedDetected 5 days ago
Project ManagementSupply ChainGMPLeadershipMentoring
About the role
- The Head of Batch Release influences site quality culture and strategic direction, ensuring appropriate quality standards and systems are in place and that they are effectively applied in accordance with regulatory guidance and Seqirus Global requirements.
- Reporting to the Site Head of Quality, the Head of Batch Release is accountable for batch release operations, is point of contact with CBER lot release, OMCL interactions, the annual product quality review, and complaint investigations at Seqirus in the Americas.
- As a Release Responsible Person, the Head of Batch Release is responsible for the certification / release of final products, including commercial and clinical trial products, and for oversight of release of raw materials, intermediate products through the production process.
Responsibilities
- In conjunction with the Site Head of Quality, the role holder provides strong leadership and strategic direction to the Quality Assurance team, mentoring and developing staff both technically and professionally (including acting as a sponsor for trainees and/or as a mentor).
- The role holder supports the management and development of the Quality Management system (QMS), including Management.
- As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
Requirements
- Experience with regulatory authorities and international inspections
- Support and guidance must be given relating to key quality decisions impacting the manufacturing and movement of raw materials, in-process, quarantined and fully released product.
- The Head of Batch Release is expected to participate in regulatory inspections, acting as a host, strategist, and/or lead presenter as required.
Nice to have
- advanced degree preferred
- Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
Compensation
- Reporting to the Site Head of Quality, the Head of Batch Release is accountable for batch release operations, is point of contact with CBER lot release, OMCL interactions, the annual product quality review, and complaint investigations at S
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
- Education and Experience
- Knowledge of appropriate regulatory requirements including GMP/GQP Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
Company info
- CSL Seqirus is part of CSL.
- At CSL, Inclusion and Belonging is at the core of our mission and who we are.
Equal opportunity
- CSL is an Equal Opportunity Employer.
- If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
- Watch our 'On the Front Line' video to learn more about CSL Seqirus
- By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
Visa & Work Authorization
- o the Quality Assurance team, mentoring and developing staff both technically and professionally (including acting as a sponsor for trainees and/or as a mentor)
This listing is sourced directly from CSL's careers page and normalized into a canonical job model.