Do you enjoy working with stakeholders and partners to help ensure compliance with company policies, procedures, and regulations related to computer system validation, electronic records and signatures, and data integrity? If so, this Manager, Computer Systems QA opportunity could be an exciting opportunity to consider.Job Purpose
As a Manager, CSQA, you will participate in projects delivering computer systems within the regulated areas of Pharma R&D and Vaccines. You will conduct computer system validation related audits to ensure compliance within GSK and external to GSK. You will also support regulatory agency inspections of Pharma R&D and Vaccines to achieve successful outcomes. All of this will be done to ensure GSK R&D and Vaccines compliance and inspection readiness with respect to applicable Pharmaceutical Regulatory Agency requirements for Computerized System Validation (CSV), Regulated Electronic Records and Signatures (RERS), Regulated Electronic Data Integrity (REDI) and GSK controls.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why you? Basic Qualifications:
- Provide input into the development of strategy, policy, CSQA objectives and processes in Global Quality Assurance and with business partners.
- Assure computer systems meet regulatory requirements and that they conform to regulatory expectations.
- Interact with regulators and/or industry experts to represent GSK interests.
- Interpret and apply regulations/policies to unique and often complex issues.
- Interpret and communicate changes in the regulatory environment that could impact GSK to proactively mitigate and resolve potential computer compliance issues. Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance across Pharma R&D and Vaccines.
- Manage routine computer compliance audits (internal & external)
- Manage computer compliance initiatives of demanding high priority including regulatory inspections and high-risk non-compliance issues (ex. lack of supporting evidence of validation).
- Manage CSQA priorities, schedules and/or initiatives to assure delivery of CSQA, GQA & GSK objectives.
- Lead CSQA initiative, program, or team activities, as required. Contribute to an environment that optimizes employee productivity and adds value.
- May develop group skill sets and knowledge base to meet the needs of a changing environment.
- Actively engage in computer compliance risk management activities to identify effective risk management strategies for identified risks. Proactively share potential computer compliance risks to the business to initiate mitigating measures.
- Act as coach/mentor to develop others with CSQA/GQA
- Represent CSQA as a primary business contact. May represent CSQA across GSK and externally
- Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers with respect to emerging technology as well as established solutions.
- Work closely with Information Technology department, system owners and business owners to effectively and efficiently implement new systems, system upgrades, or system modifications.
- Ability to travel up to 15%
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in the Life Sciences or Computer Science field.
- Five or more years experience in Computer System Validation - either conducting CSV or from a quality assurance perspective.
- Two or more years experience in Software Development Life Cycle (SDLC) principals including planning, analysis, design, development, testing, implementation, and maintenance.
If you have the following characteristics, it would be a plus:
- Experience interacting with regulators either through regulatory inspections or via industry groups.
- Experience and practical understanding GAMP and ERES standards
- Understanding of Software as a Service (SaaS) and associated compliance concerns.
- Understanding of automation and its use in computer system validation (automated testing for example)
- Knowledge of artificial intelligence and machine learning
- Understanding of the use of cloud computing in the pharmaceutical space
- Understanding of Platform as a Service (PaaS)
- High degree of organizational awareness and in-depth knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations (FDA, MHRA, etc.).
- Ability to understand and consider broader risks beyond pure compliance and/or cross-GxP risks.
- Ability to influence and negotiate at various levels internal and external to GSK.
- Work independently and engage with business areas in strategic and/or operational decisions on behalf of Computer Systems QA.
- Develop internal and/or external networks to influence key stakeholders
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting 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