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QU Program Manager

Marietta, Pennsylvania, US
Closing date
Jan 15, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Site Name: USA - Pennsylvania - Marietta Posted Date: Dec 16 2021 As a QU Program Manager, you will lead the development and management of strategic areas within the Quality Unit at the Marietta Site, including but not limited to Governance, Operational Excellence, Quality Risk Management, Project Oversight, and Continuous Improvement. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: * Partner with Quality Systems to define and deliver initiatives aimed to improve Quality indicators, with focus on deviations, change controls, documentation and other key quality systems * Maintain overview of all projects within the Quality Unit. Assist QU PMs and individuals with PMO preparation as needed * Mentor others on project planning, including financial and resource allocations, monitoring and tracking project status * Develop and track relevant project KPIs and communicate progress, risk and issue * Review meeting structure within the Quality Unit and ensure appropriate governance is in place at all levels and in alignment with GIO/Q level governance * Write and update the Site Quality Plan * Responsible to work with Global functions and other GSK sites to ensure sharing of best practices and to maintain visibility on relevant initiatives * Leading and ensuring GPS 2.0 implementation across the Quality organization. Ensure consistency of practices and tools and perform capability assessments * Continuous Improvement champion for the Quality Unit. Maintain overview of all Orange Belt/CI projects within QU. Facilitate sessions to drive a culture of continuous improvement using lean tools to identify new CI projects * Value Creation champion for the Quality Unit. Ensure that the gains obtained from improvement projects are sustained and documented as value creation when applicable * Risk Management champion for the Quality Unit. Lead the QU Risk meetings to identify, score and mitigate risks identified in QU. Point of contact with the Site Risk Manager Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelor's Degree in Microbiology, Biology/Virology, Biochemistry, Chemistry, Pharmacy or relevant technical discipline * 5+ years experience in Quality Assurance or Quality Control (Quality Systems, compliance, product release, auditing) within clinical or commercial organization with licensed biopharmaceutical or biological products. Preferred Qualifications: If you have the following characteristics, it would be a plus: * Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance * Prior experience with licensed biopharmaceutical or biological products * In-depth experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department. Strong technical understanding of industry and science practices related to the business * Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships * Preferred - Certification or training in quality systems or cGMP compliance by a recognized organization such as ASQ * Risk Management Principles and Techniques * Successful Interaction with internal and external customers, cross-functional leadership, capability to drive governance across functions and stakeholders * High learning agility and analytical skills * Flexibility, tenacity, strong logical approach to problem solving, pragmatic and results driven, can-do attitude to help the organization deliver stretch goals, structured organized excellent planner, ability to coach staff on all different levels of the Quality organization, ability to influence and get buy-in of senior management, mediate and drive critical programs forward * Be an excellent negotiator when the workload is conflicting and jeopardizes program deliverables Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Continuously looking for opportunities to learn, build skills and share learning. * Sustaining energy and well-being. * Building strong relationships and collaboration, honest and open conversations. * Budgeting and cost-consciousness. * This is a job description to aide in the job posting, but does not include all job evaluation details. * LI-GSK #MARIETTAVACCINES 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.

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