Quality Lead

GSK•Upper Providence, PA

8d•Remote

About The Position

As a Quality Lead, you will be responsible for the Quality oversight of assigned Contract Manufacturing Organizations (CMOs) to ensure MAH’s product quality, compliance and GSK’s reputation is protected, specifically for combination product device assembly including prefilled syringes/autoinjector and packaging. 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.

Requirements

Bachelor’s degree in a Science or Engineering discipline and 5+ years' experience (Manufacturing, QC, Engineering, Validation or Quality Operations) or Master's degree with 3+ years' experience
Experience with quality systems, including documentation and compliance.
5+ years' experience in various Technical, Regulatory or Quality Assurance roles with at least 2+ years of combination product and device and packaging experience.
Developing knowledge of regulatory requirements including biological products and facility licensing requirements

Nice To Haves

Developing understanding of quality systems and quality control processes.
Developing knowledge of GMP's, FDA, EU, ISO13485 and other regulatory agency requirements with an ability to apply to quality and compliance.
Developing knowledge of combination product and device regulations.
Developing knowledge of quality system principles and practical applications.
Developing 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.
Experience with work related travel
Excellent written and oral communication skills -English; Developing presentation skills
Developing influencing and negotiating skills
Capable of working independently and as a member of cross functional teams

Responsibilities

Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management with appropriate KPIs based on contractual parameters.
Ensure compliance with quality systems, Good Manufacturing Practices (GMP), and regulatory compliance for current products, new product introductions and transfers to External Suppliers.
Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching and identification of specific inspectional risks.
Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management with appropriate KPIs based on contractual parameters.
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.
Partner with GSK functions, such as Procurement, Quality, Technical and Supply 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 as needed.
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.
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.
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.
Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internals specifications, master batch records and others as needed.