Head Cell & Gene Therapy Quality Assurance, Open to flexible working
Are you energized by a highly impactful strategic role that drives quality improvement and senior stakeholder engagement? If so, this Head of Cell and Gene Therapy Quality Assurance role could be an ideal opportunity to explore.
The successful candidate will be a proven leader with a drive a motivation for improvement and innovation, looking to establish a world-leading Quality team for GSK's Cell and Gene Therapy platform that has responsibility for Quality oversight of clinical trial supplies and GMP activities (internal and external) and future commercialization of GSKs CGT assets. You will have the opportunity to grow and build out a Quality organization as the pipeline develops and progresses. The selected candidate will be a credible and influencial partner working closely with senior leaders in the CGT platform as well as Pharma Quality and PSC colleagues. As Head of Cell and Gene Therapy Quality Assurance, you will be responsible for providing strategic direction and leadership to the business and QA team. In this role you will oversee approximately 5 direct reports and team of approximately 15-20.
This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Accountable for Quality Assurance operations supporting CGT Platform globally and oversight of all related third parties and CMOs.
- Develop organizational strategy for assessing and monitoring contractors.
- Establishing the quality and compliance framework and quality resource models for any GSK GMP facilities that may be established for Clinical and commercial supply of CGT products and intermediates.
- Responsible for key quality processes including the batch record review process and routine and non-routine release for clinical trial materials manufactured by or for external GSK partners.
- Manage Pre-Approval Inspection readiness for regulatory agency inspections of R&D clinical trial supply external network manufacturing facilities to assure successful outcomes are achieved
- Lead and ensure proper staffing for a team of QA Staff, including Manager and potentially Directors
- Perform wide range of managerial duties including hiring, performance evaluation and management, career development, directly and through the activities of others
- Proactively interact with other GSK groups and leads project teams, quality councils, etc., to develop and maintain worldwide quality and consistency.
- Accountable for Regulatory GMP Inspection activity performed as appropriate (hosting, liaison and follow up)
- Provide guidance and direction on complex product investigations or system failures and other issues which may involve multiple functions.
- Makes sound judgement taking into consideration patient safety, business risk and GMP/Regulatory compliance.
- Ensure appropriate consistency of application of GMPs through interaction with Global R&D QA Directors.
- Promote and maintain a high level of GMP awareness and compliance in business partner areas and project teams.
- Approve GMP documentation, including Standard Operating Procedures from business partner areas.
- Approve Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
- Ensure compliance with internal assessment schedule
- Ensure robust quality investigation process is implemented and changes are effectively managed internally and at third parties.
- Leads steering committees, Quality Councils and other key task forces to ensure sound quality practices, to expedite clinical drug development and supply
- Actively develops and promotes cross boundary working, especially with CGT senior staff
- Ensure compliance with the third party assessment schedule.
- Ensure a robust GxP training program is implemented.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree.
- 12 or more years of experience in pharmaceutical / biopharmaceutical industry with a focus in R&D CMC and commercialization
- Experience driving simplification and continuous improvement in processes, systems and ways of working that deliver enhanced performance.
- Quality, Manufacturing, cGMP expertise (commercial or Investigational products).
If you have the following, it would be a plus:
- Cell and Gene Therapy expertise
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation.
- Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.