Quality Oversight Manager

GSK is currently looking for a Quality Oversight Manager to join our team in Rockville, MD. In this role you'll ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing /identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain presence and be accountable for key quality decision-making or quality escalations.

Key Responsibilities:

• Ensure that all GMP processes and operational personnel adhere to current local or area specific procedures, Oversee Quality Control (QC) and Warehouse (WH) areas to ensure the processes, equipment, areas, and documentation are in compliance with cGMP requirements, company policies and procedures. minimising risk of non-compliance and maintaining inspection readiness.

• Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations. Act a partner with area stakeholders by Providing guidance during GMP activities to proactively detect potential quality issues through active observation and reactively problem solving i,e, DMAIC .

• Perform spot-check of laboratory and warehouse areas to ensure compliance with quality standards that includes, testing, sampling, weigh and dispense, freeze down, BDS shipping, GMP material receipt cleaning and maintenance activities

• Carry out review of documentation ensuring that the content meets defined criteria, exceptions have been appropriately addressed, and Good Documentation Practice (GDP) is being maintained following ALCOA+ principles for data integrity, audit and traceability

• Check that areas are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated with associated remedial actions addressed within a timely manner

• Role model and foster a Quality Starts with Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety

Basic Qualifications:

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

• Associates degree
• Must have Quality experience
• 3+ years GMP experience

Preferred Qualifications:

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

• A sound knowledge of pharmaceutical compliance requirements and the ability to interpret and translate to the Site environment.
• Well-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization.
• Ability to deliver clear communications, coaching, foster a Quality Starts With Me (QSWM) culture and work with a spirit of continuous improvement

#LI-GSK

Please visit GSK US Benefits Summary to 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 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/