Senior GMP Compliance Advisor, Open to flexible working
4 days left
- Contract Type
The Senior GMP Compliance Advisor will be reporting to the Vice President , Head of Audit and Risk Management in Global Quality and will be responsible for supporting the monitoring and assessment the GMP/GDP compliance of the organization & coaching, training and educating the GSK Associates on GMP/GDP matters to address/prevent gaps. In this role you will be providing advice to maintain / ensure compliance when designing new approaches / use of new technologies. You will contribute to the development of enhanced regulations (as far as this is possible for a person in the industry).
The Senior GMP Compliance Advisor ensures continuous GMP, Regulatory & Corporate compliance through audits of GMP processes for the GSK Vaccines sites, Global Functions and External Supply Sites.
NOTE: T he role is providing oversight to all our sites and therefore location is flexible.
You will provide guidance, within the Quality function, on the correct interpretation and implementation of regulatory requirements. In collaboration with the GMP Compliance Support team:
- Perform on-site assessments and/or audits to sites and functions to identify gaps and weaknesses, as part of the inspection readiness activities for critical inspections, and in general in order to help ensuring continued inspection readiness of the sites.
- Coach associates before/during inspections to ensure they are capable to clearly address the questions/requests of the inspectors.
- Act as a writer/reviewer of responses to Health Authorities' observations
- Act as reviewer of the actual effectiveness of the most relevant Quality Commitments to Health Authorities.
You will lead the GMP Technical Meetings for the Vaccines Quality Audit Group:
- To determine the monthly schedule and support the presenters and SMEs when presenting
- Lead follow up discussions with SME's to enhance application of content to auditor audience.
- To co-ordinate the training in MyLearning
You will support audits and assessments at GSK Vaccines and Third Parties, i.e. Strategic Global Suppliers, Contractors, Licensees, Alliance Partners & future business partners.
- Lead and participate in audit/assessment engagements as an independent reviewer of auditee procedures and processes. Activities include, but are not limited to team coordination, monitoring of progress towards plan, liaison with auditee, scope definition and overall assessment of internal controls for the applicable process(es) / risk(s).
- Whether leading or participating on audits, provide leadership to ensure that audits deliver fit-for-purpose, risk-based assurance that is responsive to the current business and risk environment. Collaborate across Internal & Third Parties commercial Audit Team and R&D audit team to ensure holistic consideration of risk and business context. Ensure that audits are delivered to the highest level of quality, and are conducted efficiently, maximizing team productivity.
- Support the strategic Regulatory Inspection Management activities, i.e. assessments in preparation of strategic inspections, Health Authorities commitments verification.
- Serve as a business partner to enhance GSK's risk management capabilities and actively identify and share good practices and improvement opportunities.
- Remain current with industry trends and changes in the regulatory and GXP standards. Participate to external forums and conferences to ensure external knowledge on GMP/GDP is brought in GSK.
- Coach associates on the correct interpretation and implementation of regulatory requirements.
- Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures.
- Sit in internal forums as the GMP/GDP expert providing recommendation for novel manufacturing an control processes or for new approaches in the GMP environment with the purpose of providing advice on how to ensure continued compliance to regulations while still supporting the simplification and advancement of the use of new technology.
- Su pport development and continuous improvement of audit system and processes, including qualification of new auditors.
We are looking for professionals with these required skills to achieve our goals:
- University Degree in Biology, Chemistry, Pharmacy or Engineering
- At least 15 years of experience in a pharmaceutical/Biological environment covering various areas: QA, R&D, production, QC and project management roles.
- Strong knowledge of regulatory and GXP regulations (European, US, China, WHO, and industry publications such as GAMP, ICH, PIC/S.)
If you have the following characteristics it would be a plus:
- Demonstrated leadership ability and experience in influencing improvement activity to ensure implementation of appropriate CAPAs
- You should be able to demonstrate critical thinking.
- Experience as Inspector at National or International Health Authorities
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 in a culture of Innovation, Performance and Trust.
GSK Vaccines- Our Vaccines business is one of the largest in the world, developing, producing and distributing over 2.5 million vaccines every day to people across 170 countries.n, please visit www.gsk.com.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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