1+ months

Associate Director, GMP Biologics Quality Assurance

Waltham, MA 02452
Site Name: USA - Massachusetts - Waltham
Posted Date: Jul 27 2020

Are you looking for a Quality leadership role that allows you to leverage your technical knowledge/experience for strategic advantage? If so, this Associate Director, Biologics QA role could be an exciting opportunity to explore.

As the AD, Biologics QA you will be responsible for partnering internally/externally with Analytical Development, QC, and Stability functions to: provide necessary QA oversight; work with and influence Contract Testing Labs; support the analytical lifecycle of assigned assets; identify and implement continuous improvement opportunities.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Job Purpose:

  • 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 Pharma Supply Chain (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 and 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
  • Resolution, mitigation or rapid escalation of issues impacting quality, safety or efficacy of Specialty products.
  • Support Product Incident Alerts, Stock Recoveries and Product Recalls; Serve as Issue Management/Product Incident Recall Committee Secretary
  • Assist in development of budget as requested.

Why you?

Basic Qualifications:

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

  • Bachelor Degree in Science or Engineering discipline and minimum 8 years experience in a relevant QC, Analytical Method Qualification/Validation, Stability, or Quality Operations role - OR Masters Degree and minimum 6 years experience in a relevant QC, Analytical Method Qualification/Validation, Stability or Quality Operations role.
  • >8 years of previous Pharmaceuticals industry experience in technical or quality role(s) with at least 2 years of experience in support of biopharmaceuticals, biologics or vaccines.
  • >3 years of operational quality assurance or compliance experience.
  • Direct experience in analytical method qualification/validation and/or stability operations and Quality Assurance roles.
  • Experience with quality systems and quality control processes.
  • Experience with GMP's, FDA, EU and other regulatory agency requirements pertaining to quality and compliance for biological product and facility licensing requirements.
  • Experience applying quality and risk management principles and tools.

Preferred Qualifications:

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

  • 2+ years experience managing the implementation and continuous improvement of quality processes and procedures for external suppliers to ensure GMP expectations are met.
  • Demonstrated problem solving skills.

  • Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles.

  • Experience with work related travel.

  • Excellent written and oral communication skills -English. Proficient presentation skills.

  • Proven ability to manage teams.

  • Strong influencing and negotiating skills.

  • Demonstrated ability to develop and coach staff.

  • Capable of managing across boundaries.

Why GSK?

Our values and expectationsare 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:

  • Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

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Posted: 2020-07-08 Expires: 2020-08-28

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Associate Director, GMP Biologics Quality Assurance

Waltham, MA 02452

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