Supply Quality Audit

4 days ago

Durham, North Carolina, United States GlaxoSmithKline Full time
Site Name: Durham Blackwell Street
Posted Date: Jun

Are you energized by a highly technical quality assurance role that allows you to accelerate compliance and mitigate risk in a state-of-the-art manufacturing environment? If so, this Internal Quality Audit Manager role could be an exciting opportunity to explore.

As a Supplier Quality Audit & Compliance Manager , you will ensure GSK external third party suppliers of materials and services comply with GSK quality requirements and applicable Regulatory Authority expectations to avoid disruption to supply. This is delivered by ensuring quality requirements are clearly defined and understood by the supplier, the supplier compliance status is assessed, measured and documented for continual improvement and supplier corrective and preventive action plans are agreed and tracked to closure ensuring mitigation of identified gaps. This role involves interface with the supply base but also provides an "inward facing" contact with designated GSK site(s) to ensure effective management of supplier issues on the site .

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Supplier Audits & Compliance: Conduct supplier quality system audits within region to assess capability, manage audit scheduling, reporting, and document findings within targeted timelines, making recommendations on supplier approval status. Also perform For Cause and Target audits as needed. Manage contract auditing organizations to ensure compliance and maintain audit quality.
  • Risk Management: Identify supplier quality system risks, ensure incorporation into CAPA plans, communicate issues to internal stakeholders, and oversee the completion of corrective and preventive actions, including leading the escalation process when necessary.
  • Negotiate and implement Quality Assurance Agreements with suppliers, develop and ensure compliance with internal Supplier Quality processes .
  • L ead training as the Subject Matter Expert , participate in global and local projects to improve the quality audit management system, incorporating site-specific regulations.
  • P rovid e relevant inspection support to GSK sites undergoing r egulatory/customer audits .
  • Serve as a key interface to ensure effective communication and understanding between site business needs, Audit & Risk Management, Quality Systems Incoming Materials departments, and key GSK teams, while supporting negotiations of CDAs/NDAs related to audits.
  • Continuous Improvement & Training: Stay updated with industry trends and regulatory changes through training and self-study .
  • When needed act as deputy for Supplier Quality Audit & Compliance Director- Americas .


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree
  • 3+ years' experience in planning and executing pharmaceutical supplier audits, with strong audit techniques to identify and manage significant risks.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Masters degree
  • E xcellent verbal and written communication skills.
  • Knowledgeable in GSK quality requirements, regional/global cGMP regulatory standards, and skilled in negotiating and influencing suppliers to ensure compliance and implementation of corrective actions.
  • Capable of building effective networks with suppliers and internal stakeholders, functioning well in a matrix organization across cultural and geographical boundaries .
  • Experience with Microsoft Office applications and the ability to learn and apply new software applications as required as part of role (e.g., audits management software, remote virtual meetings management )
  • GSK Certified Auditor (or progressing through the programme)
  • Accreditation from External Quality or Regulatory Professional Organization (i.e. Regulatory Affairs Professional Society Certification (RAC), ASQ Quality Auditor Certification)


*LI-GSK

Please visit GSK US Benefits Summary t o 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.

Important notice to Employment businesses/ Agencies

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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