External Quality Lead

GSK • Rockville, MD

1d • Hybrid

About The Position

This position is responsible is for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) in an External Manufacturing specific Region to ensure MAH’s product quality, compliance and reputation is protected. This role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO(s) and with internal stakeholders. These include Procurement, Technical, Supplier Relationship, Regulatory, Business Development, Production, Site Management and other related GSK functions. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Requirements

• Science Degree with experience in pharmaceutical manufacturing and quality operations.
• Experience in Technical and/or Operational Quality roles.
• Experience managing and leading teams within a Quality function, with a focus on development and driving performance.
• Experience with Change Management.
• Manage investigation reviews and approvals for external partner deviations, CAPAs, and change controls.
• Project management Experience

Nice To Haves

• Demonstrated ability to be assertive.
• Demonstrated sense of urgency.
• Breadth in quality systems principles and practical application.
• Good knowledge and demonstrated application of quality and risk management principles and tools.
• Demonstrated decision-making capability; based on facts & data, and application of Risk Management principles.
• Technical knowledge of multiple dosage forms.
• Strong capability of statistical analysis of data trending
• Demonstrated ability to effectively multi-task.
• Strong Project Management skills and delivery.
• Excellent verbal and written communication skills; with strong presentation skills.
• Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
• Strong problem-solving skills.
• Demonstrated ability to work and collaborate in cross-functional teams.
• Demonstrated intercultural skills.
• Excellent written and spoken language skills; primary English and any secondary language is desirable.
• Demonstrated commercial acumen to effectively work with external companies
• Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands.
• Capable of working independently.

Responsibilities

• Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management with appropriate KPIs based on contractual parameters.
• Ensure regulatory compliance is managed through flow of regulatory information to and from the releasing Sites as governed by Quality Agreements.
• Monitor the quality performance of the CMO driving remedial action where necessary.
• Monitor and assess CMO’s key performance indicators, such as complaints and deviations as a mechanism to propose continuous improvement initiatives.
• Apply appropriate Risk management tools with each CMO, escalating and tracking significant risks requiring resolution, including Risk Management System (RMS) reporting to Quality Council, Local Incident Committee & Product incident Review Committee (LIC, PIRC) or other corporate governance processes, as required, to drive routine GEMBA with purpose as defined in the GEMBA Plan in order to assess the Supplier on the shop floor.
• Partner with GSK functions, such as EM Procurement, Quality, Technical and Supply (PQTS+) to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product.
• Partner with the CMO(s) to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance.
• Provide specific GMP training for contractors, where deemed necessary.
• Review and disposition batch records when responsibility falls within EQ.
• Drive periodic review of Quality Systems at the CMO(s), to complement audit processes.
• Where required, support the CMO by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions.
• Evaluate effectiveness of the CMO’s Quality Unit and systems and influence CMO(s) promoting robust systems operating under self-sufficient organizations.
• Escalate serious cGMP/Regulatory compliance issues following internal procedures.
• Support efforts that positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly distributed for incorporation in local action plans.
• Actively participate on the External Manufacturing Quality Review Meetings, identifying Quality related issues and continuous improvement opportunities, with proposals to address these.
• Review and respond to CMO(s) regulatory inspections on matters that involve activities related to GSK products.
• Assess impact of inspections and CMO responses to Regulatory observations prior to submission to the associated agency.
• Work with External Suppliers to establish effective CAPAs, in response to GSK audit observations and ensure the CMO(s) manage these to acceptable closure.
• Ensure timely communication of Quality Alert issues.
• Co-ordinate and track any continuous improvement / Quality Plans deemed necessary.
• Support or lead internal audit processes where required.
• Support technical assessment and perform Quality assessment for new product introductions.
• Review and approve significant documentation associated with the introduction or transfer of a new or existing product to CMO(s), including regulatory documents (e.g. PTDs, PIFs).
• Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internals specifications, master batch records and others as needed.
• Support or in some regions provide on time disposition of finished product manufactured by CMO(s) to meet supply chain demand.
• Oversight and management of the quality relationship with external (3rd) parties, oversight of medical device activities (performed on behalf of the GSK legal manufacturer), release of material manufactured by CMO(s), lead and/or support quality projects and initiatives within GSK.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level