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Manager, Laboratory QA

Collegeville, PA
Closing date
May 25, 2022

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Other, Manufacturing/QA/QC
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Site Name: USA - Pennsylvania - Upper Providence Posted Date: Mar 28 2022 Are you interested in a Quality role that allows you to make an immediate impact to the business? If so, this Regulatory Compliance Manager of Laboratory QA could be an ideal opportunity to explore. Job Purpose The purpose of this role is to develop strategy, policy, group objectives and processes in Global Quality Assurance group and assure Pharma R&D management that GSK's GLP and clinical laboratory regulated activities are in compliance with local and global regulations and expectations. In addition, manage and implement improvement projects, enhance monitoring programs, and provide compliance support through advice and consultancy to the GLP and clinical laboratories and related supporting functions in GSK. Develop and incorporate effective processes and procedures in Global Quality Assurance (GQA) and may contribute to business processes and procedures outside GQA Assure products meet regulatory requirements and that they conform to regulatory submissions. Interact with regulators. Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues. Lead a project, program or team activities which may include GxP. Responsible for coaching, mentoring, training, or directing the activities of staff. Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices. Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to GQA and business units regionally and globally. Liaise with customers to provide compliance advice/input. Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments. Establish improvement processes, as needed, or set specific measurable targets and goals linked to GQA/GSK business needs. Communicate and interact at various levels internally and externally to GSK. Build and maintain effective internal GSK business relationships within GQA and business units. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in related Life Science, Pharmacy, or related discipline. Equivalent experience will be considered 5+ years industry experience in a quality role in scientific laboratory research 5+ years' experience with GLP; Clinical Laboratory regulations and standards as they pertain to a global R&D organization; and proven experience of implementing written standards to achieve quality and compliance. Ability to demonstrate strategic thinking and cross-functional working to generate and define quality and audit strategies for a wide range regulated laboratory services. 5+ years demonstrated leadership and influencing skills experience to global management team level and similar level staff within a global R&D environment. Preferred Qualifications: If you have the following characteristics, it would be a plus: A country or globally recognized industry level expert in GLP or Clinical Laboratory quality and regulatory compliance. Excellent leadership, communication and influencing skills up to SVP management team including the ability to explain complex technical concepts to a non-technical audience. Experience leading a Quality Assurance group, including audit Excellent interpersonal and communication skills (both written and oral) and the ability to work productively in a team environment. Experience in performing activities relating to internal and external GLP Quality Assurance monitoring and QA monitoring of clinical laboratories. Experience in providing GLP/GCP, quality advice, and consultancy to Internal Business área contacts. Good computer skills with experience in a number of applications. Ability to work independently, use initiative and to be dependable Excellent planning, organizational, and prioritization skills Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge 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 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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