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R&D Validation Manager
2 months ago
Posted Date: Jun
If you are an employee potentially impacted and at risk of redundancy, please add the following statement at the top of your CV: "At Risk of Redundancy".
The R&D Validation Manager is accountable to perform the validation quality assurance of the GMP operational equipment and processes within R&D GMP operations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Develop and implement strategy, policy and group objectives that build competency in operational validation of clinical products.
- Accountable for building continuous improvement in to the processes and ways of working to optimize end to end quality and right first time.
- Support R&D sites on operational validation reports and standards.
- Responsible for the detection, communication and escalation of risks, and subsequent management of mitigation actions.
- Responsible for governing system validation status by review and approve R&D operation processes validation review plans.
- Assist in the implementation of Product Life Cycle management through Process Validation & Continued Process Verification at site. Accountable for team of global Quality Assurance managers, will motivate, focus and develop the team. In an inclusive environment to build a high performing team.
- Responsible for representing Quality R&D on validation, providing relevant information to governance boards and one voice of GSK internally and externally.
- Ensure a robust GxP training program, that appropriate qualification, validation and change control activities are undertaken within business partner areas.
- Responsible for quality oversight, ensuring robust quality management systems are in place.
- Participating in audits and assist in the CAPA design, and completion of CAPA actions where they sit with the validation team.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree
- 10+ years' experience in Quality function in a highly regulated environment (EMA/ FDA/ MHRA).
- 5 years in a quality management position in manufacturing or analytical testing and release.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Strong interpersonal skills with demonstrated ability to engage, empower and influence people.
- Strong leadership skills to motivate, engage and develop team capabilities
- Ability to drive change and continuous improvement
- In depth understanding of cGMP and regulations applicable to GSK in the relevant countries. (FDA/EU/WHO and other countries)
- Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolution.
- Ability to work transversally in matrix organization, with global perspectives
- Ability to make independent decisions even under pressure and navigate in grey zones
- Ability to communicate complex information both orally and in writing.
- Ability to adapt, work under uncertainty and accommodate flexible work demands.
*LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
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.
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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.
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