Our client, an innovative cell therapy company dedicated to the development of CAR cell therapies, now seek to hire a Head of Quality GMP who will lead the development, implementation and oversight of the company’s quality systems and ensure an appropriate level of effectiveness and compliance with GMP and other relevant regulations.
This hire must have equivalent Quality Management/Leadership experience in Cell Therapy drug development.
The successful candidate will develop, implement, maintain, and communicate the quality strategy, quality annual plan and quality programs throughout the company, while working closely with the COO and senior leadership team to plan and coordinate all necessary Quality activities.
This hire will be responsible for managing quality operations, training, and infrastructure, in addition to performing internal and external audits. This hire will be responsible for providing compliance oversight of all contractors/manufacturers.
Also, this hire will provide strong leadership and expertise in setting and maintaining compliance standards and will manage a team to ensure timely completion of goals and project deliverables, promoting Quality culture across functions.
This hire will be responsible for leading and managing all company Quality programs, activities, and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GMP compliance.
Responsibilities for Head of Quality GMP:
Oversee both Quality Assurance and Quality Control functions across all GMP processes.
Serve as a SME to guide the company on Quality related issues by communicating proactively and effectively with appropriate key stakeholders.
Provide leadership in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company operations, processes, and products.
Ensure the Company is kept current with all new quality-related regulatory requirements and provide guidance to senior management on the implications of any new or updated requirements.
Establish and maintain a world-class quality management system by directing and providing oversight and input into the relevant quality systems and standards including starting materials, batch release and control; change control; document management system; quality procedures, standards, and policies; audits; product complaints and recalls; quality system reporting; investigations and CAPAs; and other related areas.
Ensure appropriate procedures are implemented for Clinical QM and Clinical Development Activities adequate to achieve the goal of building quality within clinical research programs and activities, particularly focusing on a risk-based approach.
Interact with regulatory agencies in regard to GXP matters.
Lead and direct Clinical, non-Clinical and CMC staff in the preparation of quality documents for internal and/or external use.
Prepare and review QA budget.
Ensure that the company and departmental SOPs and other related documents are reviewed and developed to remain current and relevant.
Develop/maintain internal and external audit programs to satisfy contractual and regulatory requirements for GMP.
Act as the SME for optimization of new or existing products, processes, techniques, procedures, or facilities/equipment to ensure compliance with quality criteria.
Identify, select, and implement scalable software to support Quality systems.
Coordinate the Quality review of documents for regulatory submissions.
Oversee inspection readiness.
Develop and review qualification and validation plans and reports.
Optimize Quality Systems processes, including CAPA, Change Control, Document Control, Risk Management, identification of Critical Quality Events, etc.
Establish adequate GMP, GCP and GLP training programs for the Company to support aggressive growth plan.
Manage and develop Quality staff.
Conduct GMP vendor qualification audits and processes relating to clinical drug development.
Responsible for managing deviations, investigations, change control and OOS processes.
Responsible for approving master batch records and specification documents.
Responsible for review of QC analytical method validation/qualification protocols, reports, test methods and GMP test results to assess suitability of product disposition
Responsible for the full GMP manufacturing Quality oversight including product specification file
Coordinate and conduct batch record review and lot disposition (Cell Banks, DP, & Labelling / packaging).
Participate in inspection readiness preparations, corrective action responses,
Ensure / establish QP declaration across programs and supply chain. Ensure chain of custody for shipment of product.
Requirements for Head of Quality GMP:
BSc or MSc Degree in biological sciences or related Degree
10+ years of experience in Biotech/Pharma, with at least 5 years in a supervisory capacity.
5+ years of Quality auditing experience with outsourced cell therapy and/ or biologics manufacturing vendors.
Experience with European quality guidance and Qualified Persons (QP) requirements.
Experienced in all phases of drug development.
Full range of Quality experience in GMP; GCP & GLP knowledge beneficial.
Knowledge of current GXP qualification and validation expectations.
Excellent leadership and management experience with the ability to lead a team.
Excellent team player and communicator.
Ability to demonstrate flexibility in the face of shifting priorities or unexpected occurrences in development.
Experience in implementing a GMP quality management structure and processes.
Experience in the mechanism of multiple vendor’s oversight.
Knowledge of computerized systems validation.
Please phone Larry on +353 (0)1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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