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Manager, Clinical QA

Collegeville, Pennsylvania; Waltham, Massachusetts; Philadelphia, Pennsylvania
Closing date
Dec 1, 2021

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Other, Manufacturing/QA/QC
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Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia Posted Date: Oct 6 2021 Are you interested in a Clinical Quality Assurance role that allows you to make a positive contribution across the business? If so, this Manager, Clinical QA position could be an ideal opportunity to explore. Purpose of the role: Provide effective management of GCP Regulatory Agency Inspections and Issue Investigations. Lead study and functional teams as a subject matter expert for the preparation, conduct and response to GCP Regulatory Inspections. Lead cross-functional teams to fully investigate serious compliance concerns, analyze results and agree appropriate and proportional actions to address. Responsible for monitoring compliance trends from inspections and investigations; and accountable for driving quality system improvements and ensure compliance This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Support the development, management, and implementation of processes, associated written standards and job aides to support effective management of Regulatory Inspections and Issue Investigations across GSK R&D Development Coordinate and manage Regulatory Inspection activities for GCP process inspections both centrally and at Local Operating Companies. Serve as the main point of contact for inspection preparation partnering with risk managers to ensure business functions are prepared for both national and local inspections (FDA, EMA, MHRA, etc.). Ensure identification and mitigation of known quality issues and potential GCP compliance risks. Lead root cause analysis activities for any inspection findings identified and support the business in development of responses. Support the delivery of Regulatory Inspection activities for clinical programmes in partnership with the applicable CQA Programme Management Lead. Provide subject matter expertise to ensure effective inspection management. Provide proactive and regular communication of trends and performance metrics from all investigation and inspection activities across R&D to ensure effective implementation of controls, management monitoring and independent business monitoring. Establish strong working relationships with a network of contacts including clinical project team members, business function leaders, Risk Managers and Ethics & Compliance Officers. Maintain an up to date and in depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to business area processes and procedures. Additionally ensure intelligence is utilised for continuous improvement of inspection management processes. Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility. Assist in developing and maintaining customer training programmes and help deliver training within area of expertise. Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in related Health Science field or equivalent. Three or more years scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance. Three or more years experience in Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree in Clinical Research or related field. East Coast Location near major airport preferred Extensive knowledge of global, regional and national regulatory requirements and regulations Detailed knowledge of the drug development and clinical processes Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization A demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies Demonstrated experience interacting with regulatory agencies The ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively Must have a high degree of organizational awareness and working towards resolution with complex problems Have demonstrated project management skills and management of cross-functional activities Have demonstrated ability for excellent verbal, written and presentation skills 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK *This is a job description to aide in the job posting, but does not include all job evaluation details. 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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