Associate Director, Head of Batch Release

Job Summary:
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. 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.

Responsibilities:

• The role holder is responsible for certification and/or rejection of raw materials, intermediates, and drug product destined for release to market and/or clinic in compliance with applicable licenses and legal requirements. The role holder also provides oversight complaints investigations and trending in accordance with regulatory requirements, ensuring action required (e.g. recall) is completed in response to complaints or Adverse Events (AE). The role holder is integral to the site’s pandemic response obligations with key accountabilities across site and CMOs.
• 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. Review, ensuring compliance with regulatory requirements, company procedures and industry best practice. As a leader within Quality Assurance, the role holder must establish quality objectives and associated Key Performance Indicators (KPIs) for Batch Release and the QA function, and must ensure that these objectives are met.
• Locally, Batch Release must provide input at key site meetings / publications, including but not limited to Deviation Review Board, Change Review Panel, Site Stability Meeting, Continuous Process Verification, Campaign Management meetings, Material Review Board, Site Supply, Global Product Technical Complaint Forum, Quality Management Reviews and Regulatory planning meetings. Batch Release is also responsible for the Annual Product Quality Review and the Product Recall process including the annual mock recall.In addition to local responsibilities, the role holder must integrate with Supply Chain QA and Contract Manufacturing QA management to provide oversight of third-party distributors and contract manufacturing operations, especially as it relates to product technical complaints. 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.
• Develop and maintain a relationship with regulatory authorities (e.g. Health Authorities and Official Medicines Control Laboratories), authoring regulatory responses and participation in the inspection process site audits as appropriate. The Head of Batch Release is expected to participate in regulatory inspections, acting as a host, strategist, and/or lead presenter as required.

Education and Experience
Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred

• 8-10 years' experience in quality/GMP in the pharmaceutical/biotech industry including 3+ years' leadership/team management experience

• Experience with regulatory authorities and international inspections

• Demonstrated success in project management and business/QA systems

• Experience within a global matrix organization • Knowledge of appropriate regulatory requirements including GMP/GQP Different qualifications or responsibilities may apply based on local legal and/or educational requirements.

Refer to local job documentation where applicable.