What are the responsibilities and job description for the Secondment - LES Quality Business Analyst position at GSK?
Posted Date: Mar 3 2022
LES Quality Business Analyst - Biopharm
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
We are seeking a highly motivated and enthusiastic Biopharm laboratory SME to work with the LES team as part of the Quality Lab Applications Business Standards group as an LES Quality Business Analyst (QBA). The LES QBA will work closely with Biopharm supply chain SMEs and Tech developers to support the end to end delivery of a product in LES. This role can be located at any Biopharm manufacturing site in Europe and North America (BioCTL, Barnard Castle, Parma, Rockville, Upper Merion)
The successful candidate will have demonstrated an in depth understanding of Biopharm laboratory methods and data requirements along with the leadership skills to be able to facilitate harmonization of requirements across multiple manufacturing sites. The role will involve training site SME’s on the LES requirements process, ensuring requirements are harmonized across products and sites and align to the LES data strategy, communicating requirements to developers and ensuring that LES product data satisfies the requirements. Preferred qualifications include experience in a Biopharm laboratory and demonstrated leadership capabilities.
Key Responsibilities include, but are not limited to:
- Train site laboratory SME’s on the requirement gathering process in data workshops and as needed
throughout the LES product lifecycle (includes product testing requirements, stability requirements and environmental monitoring requirements).
- Facilitate harmonization of requirements across sites and products throughout the lifecycle of the product in LES. This may involve negotiating agreement of global ways of working, conflict resolution/escalation and business change.
- Review requirements to ensure they have been completed correctly and align with LES data strategy and Analytical Data Governance standards and are right first time.
- Review M-ERP data extracts, Empower and simple/complex instrument output to ensure they align with requirements.
- Attend tech developer demos (with site SME’s) to ensure the data is being built according to the requirements
- Monitor data in LES (static and dynamic) against data quality rules and metrics
- Work with sites and Tech developers to resolve data quality issues
- Review defects raised during data verification and assist with the RCA and CAPA resolution.
- Identify risks and work with Tech and users to find and implement mitigations
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- High School Diploma plus at least 10 years experience working in a Biopharm Laboratory
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- B.S in Computer Science , Chemistry/automation, Data Management or other related Sciences
- 5 or more years of experience working in a Biopharm Laboratory.
- Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers.
- Ability to analyze complex data/information/scenarios and make rational, risk based decisions which are communicated and/or escalated clearly and confidently.
- Excellent interpersonal skills with ability to interact/influence/negotiate effectively with peers.
- Ability to work well under pressure with tight timelines
- Must be flexible, adaptable and a strong team player
- Expert experience for one or more applications including chromatography data systems and laboratory information management systems
- Experience in pharmaceutical laboratory testing activities
- Experience in implementation and management of IT and automated equipment.
- Experience in Data management, Data Governance and reporting / analytics.
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.
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.
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