Site Name: Wavre, Barnard Castle, Evreux, GSK HQ, Parma, Upper Merion, Upper Providence, USA - Maryland - Rockville, Ware, ZebulonPosted Date: Jun 25 2024Please note this role can be based in in US/EU or UK.
The Advocacy and Compliance Programs Director will lead central compliance programs, partnering with functional teams to create and implement a compliance plan for quality-critical topics to ensure QMS in use.
This role has accountability for ensuring functional alignment and commitment to implementation actions and clear exit criteria for closure.Key ResponsibilitiesDescribe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.Single point of accountability in leading GSC through strategic compliance programs.Facilitate and lead creation of action plans with clear accountabilities.Determine quality compliant actions that will align with legislation, ensuring timely completion with a clear glide path to plan exit criteria.Work with functional partners in strategy, supply, MSAT, regulatory and quality to prioritize support and risk mitigation.Escalate risk through governance forums, influencing key stakeholders to get visibility, resources or funding where required to support delivery of the compliance program.Communicate with external authorities on the compliance plan status.Interact with external bodies to get industry benchmarking and trend insights.For all programs in scope ensure sustainable BAU model is in place at the end of the programExample of programs included but not limited to:Nitrosamine risk mitigationOversight of MAH operating model implementationDevice technical file remediationChina Compliance Annex I – FDA guidance alignmentKnowledge/ Education / Experience RequiredA.
Educational Background BA/BS degree or equivalent in experience - Area of Specialisation : Analytical chemistry, pharmacy, biological sciences, science related, GMPBA/BS or Masters DegreeB.
Job-Related Experience15 years' experience in Quality function in a highly regulated environment.Leadership, Project Management, Continuous Improvement, Decision Making, Problem Solving, and Communication.C.
Other Job-Related Skills/BackgroundKnowledge of regulatory expectations and data integrity.Demonstrated experience in continuous improvement and use of GPS tools.
Proven experience in managing complex projects and program of projects.Knowledge in digital applications to promote a paperless environment for GMP operations.Continuous improvement qualifications would be an advantage.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.Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
We prevent and treat disease with vaccines, specialty and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves – feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK 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.
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