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Director, Engineering Quality (Pharma/Biotech)

Company

GSK

Address , Zebulon, 27597, Nc
Employment type
Salary
Expires 2023-07-28
Posted at 11 months ago
Job Description
Site Name: Durham Blackwell Street, Philadelphia Walnut Street, UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, UK - North Ayrshire - Irvine, UK - West Sussex - Worthing, USA - Maryland - Rockville, USA - North Carolina - Zebulon, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper Providence
Posted Date: May 22 2023


Are you energized by a highly visible role that allows you to influence senior stakeholders and shape highly effective business partnerships? If so, the
Director, Engineering Quality role could be an excellent opportunity to explore.

As a Director, Engineering Quality, you will engage at a leadership level across the business unit, driving the strategic business plan for the business unit, supporting strategy and decision making with critical business insights.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Provide the framework to maintain audit readiness and compliance expectations of GSK QMS and the regulators for Engineering Quality, including commissioning and validation of facilities, utilities, and equipment. Provide technical subject matter expertise to the Quality audit functions.
  • Interface and build robust partnerships across GSK (WREF, IT, Supply Chain, Engineering, Quality functions, Sites) to deliver Engineering Quality Assurance expectations; reveal and solve problems across the business in managing these expectations.
  • Provide input, direction, and business sponsorship / leadership to the GSC Quality strategy deployment programs and ambition. Align and deliver programs to meet operational targets.
  • Negotiate between GSC Supply Chain Quality and central Engineering as needed to drive the standardization of site Engineering business processes, equipment, facilities, and engineering IT systems.
  • Influence the strategy, selection, architecture and integration of Engineering contractors, systems, facilities, utilities, and equipment across the GSC supply chain. Ensure the required Quality assurance processes are embedded. Authority to pause global Engineering projects at critical project decision gates if key criteria for Quality are not met.
  • Provide input, direction, and sponsorship / leadership to the GSC Quality team responsible for quality risk management of Engineering systems, facilities, utilities and equipment, into Pharma factories. Provide advice to External and Supplier Quality Operations team, supporting their work with contractors and suppliers.
  • Ensure the team receives the necessary training and experience to operate with the key principles of the GPS framework and to advance within the GPS maturity roadmap. Embed performance management systems to insure both Lead and Lag measures actively track progress to the agreed functional targets and problem-solve issues as necessary. Use GEMBA to reveal problems and support the definition of appropriate target conditions.
  • Assess skills, knowledge, and ensure robust development and capability plans are developed and embedded within Engineering and within own team. Provide training and development opportunities and serve in a coaching / mentoring role to support both individual and team growth.
  • Build and maintain a strong business and technical link with central Engineering, Vx Engineering and external bodies such as ISPE to maintain currency of technical know-how.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • A minimum of 10 years’ experience managing the design, delivery, and support of GxP engineering systems and/or production or new product introduction within the pharmaceutical industry.
  • Experience managing and/or leading projects including development of business case, implementation plans and financial controls.
  • Experience delivering an organizational change management initiative
  • Experience with pharmaceutical processing, validation and cGMPs.
  • Bachelor’s Degree in engineering or Science discipline

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Professional Engineering registration a plus.
  • Experience managing Engineering suppliers / contract providers and ensuring relevant Quality management system standards embedded into daily operations.
  • Six Sigma and Lean Manufacturing experience; Black Belt or Green Belt desirable
  • Experience driving Quality Standards into an Engineering or Technical Organization
  • Excellent written and oral communication skills
  • Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers
  • Ability to recruit and motivate highly skilled and trained individuals
  • Proven technical and leadership skills
  • Critical thinking and problem-solving skills to investigate issues and determine root cause.

Why GSK?

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicine and vaccine doses in 2022.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

#LI-GSK

  • This is a job description to aide in the job posting, but does not include all job evaluation details.

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.