Are you energized by a highly specialized technical role that leverages the latest in quality analytical technology and method development?  If so, this Quality Manager – US Fill/Finish (Remote, External Manufacturing) role could be a great opportunity to explore.

As an Operational Quality Manager, you will be the face of GSK Quality at contract manufacturing organizations (CMOs) in the External Manufacturing (EM) network focused on fill/finish operations e.g., aseptic drug product filling, combination product device assembly (e.g., pre-filled syringes, auto-injectors), packaging. Ensure CMOs operate in accordance with GSK and industry practices and standards (e.g., combination Product GMPs, Annex 1, ISO 13485) through your strong manufacturing, technical, and/or operations background. Maintain regular on-site presence during manufacturing to provide real time problem solving, support, influence, and decision making to assure the Quality and compliance of GSK’s products and maintain GSK’s reputation.  Travel up to 30% unless you are co-located with the CMO(s) in their remit.

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

• Provide Operational Quality (OQ) oversight throughout the product and CMO life cycle, including but not limited to:

• CMO and supply chain selection and enabling e.g., due diligence, Quality Agreement, audit

• Product enabling technology transfer, PQ readiness, registration

• Routine operations e.g., on-site presence and Quality direction during manufacturing (e.g., real time problem solving, support, influence, decision making), deviation and incident management, batch review, change controls, batch disposition, periodic product reviews

• Audit/inspection e.g., inspection preparation / management / response, on-going inspection readiness, time cycle audit support

• Conduct OQ duties in accordance GSK’s standards and QMS e.g., CAPA / deviation / change control / document management, Quality Agreement maintenance, KPI reporting, internal audit

• Maintain current knowledge of the GxPs and optimize GSK’s Quality Management System (QMS)

• Build and maintain strong and credible relationship across GSK and CMO functions to ensure effective OQ oversight while optimizing the quality mindset, promoting maturity, and safeguarding the quality / compliance of GSK’s products

• Maintain current knowledge of GSK and industry sterile / aseptic drug product manufacturing, combination product manufacturing including filling and device assembly, and packaging standards and a strong and collaborative working relationship with the GSK SME community

• Establish, maintain, improve, and contribute to operational and governance forums: 1) Internally e.g., Quality Council, Risk Management Control Board 2) With the CMOs e.g., internal and joint project team meetings, Business Reviews, Steering Teams

• Assure potential and known issues, risks, and opportunities are communicated and managed within the GSK systems while ensuring teams, leadership, and stakeholders are appropriately engaged in a timely and effective manner e.g., escalation

• Support and deliver GSK performance and quality standards to ensure business / supply continuity without compromising quality or compliance e.g., right first time, adherence to schedule

• Lead, manage, coach, mentor, retain, and develop staff

• Proactively identify continuous improvement opportunities and deliver both improvements and benefits

 Why you?

Basic Qualifications:

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

• Bachelor’s degree in Scientific discipline or engineering discipline and 8+ years of experience or

• Master’s degree and 6+ years of experience

• Minimum 3+ years of medical device assembly or combination product experience (e.g., auto-injectors, pre-filled syringes)

• 7+ years of previous pharmaceuticals industry experience in manufacturing, technical, and/or quality role(s)

Preferred Qualifications:

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

• Oversight of external manufacturing operations (e.g., CMOs)

• Management and development of direct reports 

• Support of medical device / combination product complaint investigation and management as well as product performance trending

• Combination product (CP) development programs, ideally for pre-filled syringe (PFSs) and/or Autoinject