Manager, Biologics QA, Open to flexible working
3 days left
- Contract Type
Are you looking for a Quality leadership role that allows you to leverage your technical knowledge/experience for strategic advantage? If so, this Manager, Biologics QA role could be an exciting opportunity to explore.
As the Manager, Biologics QA you will be responsible for partnering internally/externally with CMC development partners, pharma supply chain partners to: provide necessary QA oversight; work with and influence Contract Manufacturing Organizations; support the CMC development/regulatory filings 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:
- Manage Speciality API, aseptic fill finish, 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.
- 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
- 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
We are looking for professionals with these required skills to achieve our goals:
- Degree in Science or Engineering discipline and at least 7 years' experience (Manufacturing, Engineering, Validation or Quality Operations) OR Masters and at least 5 years' experience AND/OR equivalency in education and experience.
- Experience with technical (aseptic fill finish/drug product), quality and regulatory knowledge of current biopharmaceutical manufacturing techniques/ processes
- At least 7 years of previous BioPharm industry experience in technical or quality role(s) with at least 2 years of API, biopharmaceuticals, or sterile manufacturing. Sound understanding of quality systems and quality control processes.
- Experience with GMP's, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance for biological product and facility licensing requirements. Experience with quality system principles and practical applications.
If you have the following characteristics, it would be a plus:
- At least 2 years of operational quality or compliance experience or other relevant experience
- Experience with work related travel
- 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.
- Solid understanding of Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Change Management.
- Understanding of drug substance/drug product development and manufacturing activities.
- Strong influencing and negotiating skills
- Demonstrated knowledge and ability to apply quality and risk management principles and tools.
- Demonstrated problem solving skills.
- Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles
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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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, colour, 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.
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