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

Why you?

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

The annual base salary for new hires in this position ranges from $96,525 to $160,875 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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).

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