Compliance Specialist

Site Name: Cambridge Binney Street

Posted Date: Mar 22 2024

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

GSK has an exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right first-time performance. The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.

Key Responsibilities:

• Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,

• Lead CAPA investigations and at times manage the implementation of CAPA.

• Own manufacturing related change controls.

• Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.

• Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.

• Review production documentation and perform quality walk-throughs during manufacturing events

• Participate in continuous improvement teams such as 5s, Gemba and the GSK Production Systems (GPS).

• Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.

• Lead team meetings and facilitate multidepartment discussions.

• Stay current with biopharmaceutical industry best practices and technologies.

• Other duties as assigned

Why you?

Basic Qualifications:

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

• Bachelor's degree or equivalent experience.
• 3+ years of GMP experience.

Preferred Qualifications:

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

• This job is on-site M-F at Binney Street in Cambridge. There is limited ability to work from home

• Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.

• Ability to meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.

• Ability to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.

• Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).

• Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).

• Good computer skills, knowledge of Microsoft office products - Word, Excel, Office.

• SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single use technology (SUT), buffer preparation and filtration.

• Experience with regulatory agency interactions and inspection discussions preferred but not required.

• Excellent verbal/written communication skills.

• Facilitation and demonstration skills

• Attention to detail and the ability to work individually and within multi-disciplinary teams

• More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization 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.

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