Compliance Specialist

Are you looking to enhance your technical capability by working in a global manufacturing environment that allows you to leverage best in class systems and technologies? If so, this Compliance Specialist role could be an ideal opportunity to explore.

As a Production Manufacturing Operations Manager, you will contribute to troubleshooting and continuous improvement by leading deviations (unplanned events) investigations (identifying root cause through root cause analysis, writing respective reports and determining CAPAs), as well as by coordinating changes as needed to maintain the operational systems and facilities compliant and in a state of control.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Contribute to process troubleshooting activities, by leading deviations investigations, effectively interacting with owners, QA, SMEs and other stakeholders as needed, using RCA methodologies to identify root cause and effective CAPAs, and authoring clear and concise related reports.
• Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety.
• Prepare clear, concise reports from outcome of investigations, using systems such as SAP.
• Review/create/update documentation including batch reports, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.
• Contribute to continuous improvement implementation activities, by coordinating changes (e.g., change controls) as needed.
• Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

Why you?

Basic Qualifications:

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

• Bachelor's degree
• 2+ years of prior pharmaceutical (or related industry) experience working in a technical role (e.g., Validation, Engineering, Manufacturing, Industrialization, Development, Automation, Operations, QA, QC or related).

Preferred Qualifications:

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

• Prior experience with Quality System Management (Deviation investigation, Change Management, CAPAs, etc.) in a regulated environment
• Proficient with MS Office applications including Excel, PowerPoint and Word and the ability to learn and apply new computer programs quickly. The ability to create, interpret and modify data in Excel is required
• Demonstrated problem solving and investigational skills.
• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
• The ability to clearly write technical documentation.
• SAP skills are a plus
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines

Why GSK?

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.

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 Get Ahead Together.

#LI-GSK

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 impact the health of 2.5 billion people around the world in the next 10 years.

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.