• Job Description

  Req#: 411201

  GSK is currently looking for a GMP Quality Assurance Manager to join our team. In this role you’ll manage specialty API, bulk drug substance, analytical testing, drug product, and/or packaging external manufacturing quality assurance operations and compliance activities with leadership and direction of R&D project team(s) and PSC supply, technical and specialty product team(s). Provide and/or facilitate decisions concerning the quality of material disposition or rejection. Responsible for the Operational Quality management relationship with strategic partners, alliances & external supply contractors for Specialty products. Responsible for assuring timely supply of product & maintenance of GSK reputation from a quality perspective. Contribute to the establishment of GSK Quality Standards for products within the scope of Specialty External Manufacturing. Manage issues and risks identified in area of responsibility.

  Key Responsibilities:

  • Recommend and manage implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met.
  • Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met.
  • Establish, implement and sustain an operational quality oversight model in compliance with GSK quality expectations & accounting for contractual complexities & strategic project requirements
  • Supports the governance structure for quality oversight of External Suppliers that assures GSK product are in compliance with registered detail, QMS requirements and Specialty External Management Processes
  • Directly manages external suppliers as assigned.
  • Manage activities to ensure on time/Right First-Time testing and disposition of bulk drug substance & finished product manufactured by External Suppliers to meet supply chain demand.
  • Assure quality issues are managed to safeguard GSK's patients, ensure business continuity & protect reputation.
  • Contribute to and manage implementation of quality strategy from the QMS or from project leads as applicable.
  • Where deviations from the above policies or the manufacturing process occur, e.g. registered detail, resolve, mitigate or escalate to senior management as judged necessary
  • Actively manage records produced by External Suppliers, to ensure timely and appropriate outcomes for Quality and Production systems.
  • Develop/negotiate or maintain quality agreements as required by QMS.
  • Assurance that GSK's Quality Management System is applied to External Supply practices demonstrated through effective Quality Agreements, GSK Corporate audits & delivery of successful regulatory inspections.
  • Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching and identification of specific inspectional risks.
  • Report and drive resolution of cGMP/Regulatory compliance issues. Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate, Legalized and Notarized Declarations and documents as required by for LOCs.
  • Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
  • Maintain regular dialog with team members, individually and collectively, providing feedback and recognition. Monitor the training status of direct reports

  Why you?

  Basic Qualifications:

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

  • BS degree and at least 4 years’ GMP experience in biologics Manufacturing, QC, Engineering, Validation or Quality Operations OR Masters and at least 2 years’ experience GMP experience in biologics Manufacturing, QC, Engineering, Validation or Quality Operations

  Preferred Qualifications:

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

  • Thoroughly knowledgeable of cGMP's and applicable ICH guidelines.
  • Demonstrated sound decision-making skills.
  • Demonstrated ability to lead work and collaborate within cross-functional teams.
  • Strong verbal, written communication and presentation skills.
  • Able to prioritize and decide appropriate course of actions.
  • Strong Project Management skills.
  • Solid understanding of Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Change Management.
  • Leads root cause analysis activities as necessary using established tools.
  • Supervisory experience necessary (1-3 years).
  • Operational Excellence exposure.
  • Prior contractor management experience desirable.
  • Strong interpersonal and influencing skills.
  • Demonstrated flexibility, ability to adapt and accommodate different/ multiple work demands.
  • Strong understanding of current FDA/EMA validation practices including sterilization, cleaning, performance process qualification, shipping, computer systems, analytical methods.
  • Solid understanding of drug development and clinical manufacturing activities.

  #LI-GSK

  The annual base salary for new hires in this position ranges from $107,525 to $145,475 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

  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 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.

  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.

• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

Notice