Quality Assurance Manager

Overview of Role:

The QA Manager will lead and manage quality assurance activities to ensure compliance with EU GMP, regulatory requirements, and company standards. This role involves oversight of quality systems, batch release processes, audits, and continuous improvement initiatives. The QA Manager will act as a key liaison between manufacturing, regulatory, and quality teams to maintain product integrity and patient safety. This position will also oversee quality systems, support product development and commercialization, and ensure that all activities align with Summit's mission to deliver safe, effective therapies to patients.

Role and Responsibilities:

• Oversee remote batch release operations, ensuring real-time quality oversight of manufacturing and testing conducted at global contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs). Manage batch documentation reviews and approvals using digital QMS platforms and electronic batch records (EBRs).
• Collaborate with CMOs, CDMOs, and supply chain partners to ensure seamless support to the Qualified Person (QP) in batch certification and release activities.
• Ensure timely review and approval of batch records and associated documentation.
• Act as responsible person (RP) SME, is responsible for ensuring that the product is transported, stored and delivered according to the license and in compliance with GDP regulations. In addition, the RP is responsible for ensuring that the product is not tampered with, stolen or counterfeited during distribution.
• Maintain and improve the Pharmaceutical Quality System (PQS) in compliance with EU GMP and ICH guidelines.
• Oversee CAPA, change control, deviation management, and risk assessments for EU quality system.
• Ensure compliance with EU GMP, ICH guidelines, HPRA, and EMA regulatory requirements.
• Provide leadership on quality assurance (QA) and quality management system (QMS) initiatives. Ensure SOPs and quality documentation are current and compliant.
• Deliver GMP training and support junior QA team members.
• Conduct audits of CMOs, CDMOs, and suppliers to ensure compliance with GMP standards.
• Prepare for and host regulatory inspections and internal/external audits. Implement corrective actions and continuous improvement plans.

Experience, Education and Specialized Knowledge and Skills:

• BSc/MSc/PhD in Pharmaceutical Sciences, Chemistry, Biology, or related discipline
• Minimum 5+ years of experience in a GMP-regulated environment within the pharmaceutical or biotechnology industry
• Experience in remote batch release, electronic batch records (EBRs), and digital QMS systems
• Strong knowledge of good distribution practices (GDP) with an RP background.
• Strong knowledge of EU regulatory requirements, HPRA/EMA expectations, and GMP compliance for global supply chains
• Experience in managing audits and regulatory inspections.
• Experience working with CMOs/CDMOs and managing outsourced manufacturing.
• Proven ability to lead and influence in a cross-functional, global team setting.
• Strong problem-solving skills and ability to manage complex quality issues remotely
• Excellent communication, leadership, and problem-solving skills.

Desirable:

• Experience in sterile manufacturing or biologics.
• Eligibility or aspiration to become a Qualified Person (QP).
• Experience working in a 'virtual' BioPharma company would be desirable but not essential.
• CMO Oversight experience would also be beneficial.

What We Offer

• Competitive salary and benefits package.
• Opportunity to work in a dynamic, innovative environment.
• Career development and training support.