Manager, Cell and Gene Therapy QA - External Quality, Open to flexible working
Are you energized by leading the oversight of third parties involved in Manufacturing and leading a team in providing Quality Assurance and continuous improvement in the assigned third parties ? If so, this role could be a great opportunity to explore.
As a Manager, Cell and Gene Therapy QA - External Quality, you will be responsible to ensure effective oversight and ensure a high level of compliance at third parties and of any GSK activities. You will have experience in batch review and disposition, ideally an understanding of Cell and Gene Therapy or Biopharm products and their use in clinical studies. You maybe required to be an SME for certain Quality systems, own, author or approve SOPs or quality processes. You will also work closely with the CGT QA team and the wider PQPRD and Pharma Quality teams to support alignment of system and processes and continuous improvement. You will identify, communicate and escalate risks and concerns, and provide suggestions and approaches to effectively manage risks.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Provide input into the development of strategy, policy, group objectives and processes in Product Quality Pharma R&D and with business partners
- Assure products meet regulatory requirements and that they conform to regulatory submissions.
- Interact with regulators and/or industry experts to represent GSK interests
- Interpret and apply regulations/policies to unique and often complex issues.
- Manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
- Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.
- Lead a project, program or team activities which may include GxP.
- Contribute to an environment that optimizes employee productivity and adds value.
- Develop group skill sets and knowledge base to meet the needs of a changing environment.
- Direct the activities of one or more direct reports or lead a matrix team or business process.
- Actively engage in risk management activities to identify effective risk management strategies including the escalation of risks and their solutions.
- Act as a coach, mentor or trainer to develop others.
- Represent the group as a business contact or on a quality forum/council.
- Proactively identify, communicate and monitor business/regulatory changes that could impact on quality or compliance across Pharma R&D.
- Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers.
- Communicate and interact at various levels internally and externally to GSK.
- Develop internal/external networks to communicate with key stakeholders.
- Engage with the business in strategic/operational decisions on behalf of the group.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors Degree in Science
- Experience in a Quality role as a Front Line Leader (gained working in a Pharmaceutical R&D and/or Manufacturing Facility).
- Experience with Batch review and disposition for IMPs.
- Experience working and providing assurance of quality in third parties
- Experience with Deviations, customer and vendor complaint processes, Quality and Technical agreements
- Experience with IT systems and Data Integrity Requirements, and change control.
If you have the following characteristics, it would be a plus:
- Experience in CGT or Biopharm clinical product manufacture and supply.
- Knowledge of GSK audit systems and processes
- Excellent knowledge of current GxP requirements within major pharmaceutical markets (particularly GMP and the application for investigational medicinal products and Cell and Gene Therapy or Biopharm Products).
- Excellent knowledge and application of the principles of the Quality Management Systems (QMS) and continuous improvement
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.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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, color, 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.