Manager, Cell and Gene Therapy QA - Quality Systems and Processes, Open to flexible working
Are you energized by a highly specialized Quality role that leverages the latest in Quality systems and processes for Cell Gene Therapy? If so, this role could be a great opportunity to explore.
As a Manager, Cell and Gene Therapy QA - Quality Systems and Processes, you will lead the Quality functions efforts to establish and improve quality systems and processes specific to the Cell and Gene Therapy platform supporting GMP activities. You will be a lead Subject Matter Expert in CGT Quality Systems and processes and lead or support a number of governance or monitoring activities. You will develop and maintain the CGTQA Training curricula to ensure appropriate role based curricula are in place of the CGT QA team. You will be engaged in may be required to lead Tech projects deployed in the CGT platform or Quality function. You will also work closely with the QMS team and other quality groups at GSK to align and streamline processes and systems, whilst supporting and championing requirements and ways of working for the CGT platform.
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 that fundamentally raise the importance of quality/compliance within Pharma R&D.
- Assure QMS meets regulatory requirements and processes and systems are efficient and effective.
- Interact with regulators and/or industry experts to represent GSK interests
- Possess the ability to 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.
- Lead and direct effectively in a dynamic matrixed environment to drive business results and build a performance based culture
- Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives as maybe required / assigned..
- Build an environment to optimize employee productivity and added value to the organization by actively leading a site or business team which may include GxP.
- Develop group skill sets and knowledge base to meet the needs of a changing environment.
- 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.
- Strategic contact with business groups or on a quality 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 on key indicators and added value to internal/external customers.
- Communicate and interact at various levels internally and externally to GSK.
- Create an environment where open, transparent communication is valued and trusted.
- Effectively utilize 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:
- Bachelor 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 IT systems and Data Integrity Requirements, change control and computer system validation.
If you have the following characteristics, it would be a plus:
- 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, 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.
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