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Associate Director / Manager, Pharmacovigilance QA (Quality Assurance)

Collegeville, Pennsylvania; Research Triangle Park, North Carolina; Waltham, Massachusetts
Closing date
Aug 17, 2022

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Other, Manufacturing/QA/QC
Job Type
Manager, President/CEO/Director/VP
Organization Type
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Associate Director / Manager, Pharmacovigilance QA (Quality Assurance)

The purpose of this role is to provide PV Quality Assurance within GSK R&D, by (1) providing input into the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program across GSK R&D, (2) Identifying compliance issues, monitoring trends and (3) being accountable for driving quality improvements back into Global Safety and improve PVQA processes.

The successful applicant will lead holistic QA activities by supporting the business, being involved in PV regulatory inspections and building solid working relationships with Global Safety stakeholders to build network of contacts while maintaining knowledge of local regulatory frameworks and global regulatory reporting requirements.

In this role you will
  • Assist in the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program
  • Develop, implement and assess PV quality assurance strategies, organizational and operational needs.
  • Independently manage comprehensive PV/MV quality assurance programs and assess adherence to quality standards and compliance with PV/MV, International regulations and Guidelines, and GSK policies and procedures. Independently plan, lead, and conduct routine and complex audits of PV activities within Global Safety, LOCs, External Service Providers and Licensing Partners to assure compliance with PV regulations, GSK policies and procedure, and applicable local regulations.
  • Be responsible for primary internal customer base including Global Safety, LOCs, Safety Governance, Risk Management, QPPVs, GRA
  • Lead PV consultancy efforts with Business Units and / or regions, as appropriate
  • Pro-actively perform as a risk-management consultant, providing expert advice in relation to obtaining compliance, quality improvement, holistic quality initiatives, and risk assessment
  • Collaborate with Global Safety staff to interpret international regulations and guidelines and establish and monitor compliance for acceptable standards for PV/MV activities
  • Be responsible for training and providing feedback to peers
  • Act as inspection coordinator for PV related regulatory authority inspections of GSK
  • Generate and provide metrics, status and periodic reports and other information to identify trends and develop improvements across the business
  • Act as a consultant and represent PVQA to central and local safety teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment
  • Provide expert advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment, and act as point of contact for customers and CQA staff for PVQA
  • Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines that affect the business
  • Maintain an in-depth knowledge of PV processes and procedures
  • Develop and maintain a network of contacts with other quality and compliance groups as well as client areas
  • Educate, guide and influence GSK management and staff on best quality and compliance practices, especially as they relate to areas of identified responsibility
  • Build and maintain beneficial working relationships with all internal and external customers
  • Support the recruitment of new PVQA staff
  • Develop PV training program to PVQA advisors
  • Interact with regulatory agencies in designated region(s) as appropriate or as needed

Closing Date for Applications: 28th August 2022 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.


Why you?

Qualifications & Skills:

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
  • A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and drug safety
  • Good Pharmacovigilance Practice Compliance, Good Clinical Practice Compliance and/or Quality Assurance, Drug Development experience
  • Expert knowledge of global, regional and national PV regulatory requirements and regulations
  • Detailed knowledge of the drug/clinical development processes and R&D Systems
  • Detailed knowledge of pre and post marketing PV/MV activities associated with different areas of the business (e.g., clinical trials, manufacturing, regulatory affairs, commercial, toxicology)
  • Proven ability to influence and negotiate with key internal and external stakeholders
  • Ability to deliver key process improvement initiatives
  • Ability and desire for frequent domestic and international travel (approximately 25-40%)

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:
  • Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members
  • Ability to work independently and make decisions with minimal supervision
  • Must have a high degree of organizational awareness and working towards resolution with complex problems
  • Have demonstrated project management skills and management of complex cross-functional activities
  • Have demonstrated ability for good verbal, written and presentation skills

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021


We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D

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.

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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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