Senior Advisor CGT QA, Open to flexible working
GSK have an exciting opportunity for a Senior QA Advisor to join the Cell Gene Therapy team at Stevenage site on a full-time and permanent basis.
To perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. There will possibly be up to 25-30% travel required to UK and Germany for this role.
- Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D
- Assure products meet regulatory requirements and that they conform to regulatory submissions.
- May interact with regulators.
- May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
- May lead a project, program or team activities which may include GxP.
- May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports.
- Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
- Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
- Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
- May represent the group as a primary business contact for specific areas.
- Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally.
- Liaise with customers to provide compliance advice/input.
- Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
- Establish improvement processes, as needed, or set specific measurable targets and goals linked to GSK business needs.
- Communicate and interact at various levels internally and externally to GSK.
- Build and maintain effective internal GSK business relationships within business units.
Specific Accountabilities that may be performed based on training:
- Approve GMP documentation, including Standard Operating Procedures, validation documentation, change controls, and other controlled documents from business partner areas.
- Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
- Perform internal assessments to measure compliance with appropriate GSK policies and procedures.
- Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
- Perform 3rd party management activities, including audit of suppliers and contract resource organizations, utilizing third party assessment procedures.
- Initiation and maintenance of Quality Assurance Agreements
- Develop and deliver GxP training to business partners.
- Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval.
- Generate, review and approve batch and/or packaging record templates.
- Conduct review of completed batch and/or packaging records.
- Perform material release activities (US Only)
- Ensure that the third party assessments are available to support material release
- Generate and approve relevant release documentation
- Provide project support including preapproval audit activities.
Closing Date for Applications: Monday 21st June 2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in a Science discipline.
- Proven experience in a lead Quality Assurance role working in a Pharmaceutical R&D and/or Manufacturing Facility.
- Experience reviewing master batch records or / and executing batch records.
- Experience working with and providing assurance of quality in third parties (CMOs / contract manufacturing / contract resource organizations).
- Experience with Deviations, customer and vendor complaint processes, Quality and Technical agreements.
- Hands on experience following Good Manufacturing Practices (GMPS) in the biopharma / pharmaceutical environment.
- Experience with the application of Quality Systems in manufacturing, warehousing and distribution.
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.
- 5 years of Manufacturing or R&D /Quality experience in the Pharmaceutical industry.
- Experience with Batch review and disposition for IMPs for phase 1, 2, and 3.
- Experience with IT systems and Data Integrity Requirements, and change control.
- Ability to work independently and prioritize workload.
- Excellent oral and written communication skills.
- Strong interpersonal skills with an ability to enable and drive change.
- Problem identification and solving skills.
- Experience of working with multi-functional teams.
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:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
At GSK, we're a company with a special purpose, to help people do more feel good and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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