Americas GMP Audit Senior Lead

Are you an experienced Biopharma or Pharma Professional looking for a challenging opportunity to leverage your expertise to assist GSK Senior Management in the identification, prioritization and monitoring of quality, compliance and technical risks? If so, this role within our Quality organization could be a great position for you to explore.

Position Details:

The primary purpose of the Audit Senior Lead is to perform and manage GMP compliance audits of Medicines and Vaccines sites supplying highly regulated markets. In this role, you will provide additional Biopharm subject matter expertise within the GSK Medicines Supply Chain Americas auditing team. You will be responsible for evaluating the level of compliance of Medicnes and Vaccines Supply Chain Internal and External facilities, manufacturing operations, and Local Service Providers with Good Manufacturing Practice, applicable facility policies and procedures and regulatory and contractual commitments. Your excellent communication and influencing skills will be a key deliverable for success in the role.

Location: This position will be located at a GSK Site or Central Function office (e.g. Durham, Philadelphia, Rockville, Upper Merion, Marietta, St Foy, Hamilton, Binney Street or Zebulon) and require an on-site presence.

Travel: Approximately 30% travel is required in the USA primarily, as well as Central and South America.

Application Cover Letter: Please support your application with a cover letter detailing how your skills and experience meet the role requirements. Also, please indicate your preferred on-site location.

Key Responsibilities:

• Preparation of clear concise and objective audit reports of the highest level of quality that ensure that senior management is appraised of the identified risks and that appropriate corrective action plans are implemented.
• Manage the interface with auditees and stakeholders (the latter may include Site Directors, Site Quality Directors, Heads of Support Functions).
• Promote early visibility of regulatory / compliance issues.

• Expand knowledge base through proactive knowledge sharing and collaboration.
• Achieving excellence in subject matter expertise to enhance the quality of audits provided.
• Develop self and others through giving and receiving feedback to promote excellence and continuous improvement.

• Provide input to Global QMS Documents and functional processes.

More experienced staff may undertake:

• Manage the interface with auditees and stakeholders (the latter may include Supply Chain Directors, Site Directors, Site Quality Directors, Heads of Support Functions, Research & Development Quality)

Typical work output will involve:

• Entity audits of GMS and external manufacturing sites supplying highly regulated markets.
• Preparation of clear concise and objective audit reports of the highest level of quality that ensure that senior management is appraised of the identified risks and that appropriate corrective action plans are implemented
• For-Cause audits based on regulatory actions or identified risk.
• Progress audits against risk mitigation plans or regulatory citation commitments.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science degree in a Scientific and/or engineering discipline.
• 10+ years experience in the pharmaceutical industry including 5 years experience specifically in Biopharm / Steriles / Aseptic related industries.
• Experience with /good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for pharmaceuticals, APIs, and biopharmaceuticals.
• Experience identifying and/or managing quality compliance issues.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Broad based understanding of Primary and Secondary manufacturing.
• A working knowledge and competency in evaluation of ALCOA+ principles within the Pharma industry.
• Excellent written, verbal, questioning, and listening skills.
• Digital skills capability and demonstrated usage.
• Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, Heads of Support Functions).
• Ability to utilize critical thinking of complex quality systems and processes.
• Understanding and experience of corporate governance processes.
• New Product Introduction requirements.
• Risk Management knowledge, application and evaluation.
• Application of continuous improvement, change control and risk assessment.
• Previous auditing experience preferred (e.g. Proficiency & experience in planning, performing & reporting Quality or Regulatory Compliance audits).
• Reading and verbal Spanish language communication skills is considered a plus.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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