Senior Specialist, Quality Assurance Vaccines

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Under the general direction of the Associate Director, Wilson Quality Operations, the Sr. Specialist is primarily accountable for support of Quality Assurance activities within the POD facility at the Wilson, NC Site.  This position will be a member of the Quality team within the Integrated Process Team.

The Sr. Specialist will be responsible for quality activities to support commissioning, start up, licensure, and continuing operations for the POD facility at the Wilson site.  The position is accountable for comprehensive oversight/management associated with the applicable Quality systems ensuring that business objectives are met within budgetary constraints and that a high standard for Quality and EHS compliance is maintained.  The position will also be expected to promote behaviors of continuous improvement aligned with Company Production System principles and ensure that the Quality team maintains an inclusive culture that promotes positive employee relations. 

Specific leadership principle expected of the Sr. Specialist include: 

• Contributes to the performance and results of the Quality department and POD IPT
• Schedules and coordinates the workload of the larger team
• Adapts, plans, and prioritizes to address operational challenges
• Executes activities to ensure that all safety and compliance regulations are adhered to and enhanced, where applicable
• Executes activities to meet or exceed customer expectations
• Anticipates and interprets customer needs to identify solutions
• Provides technical guidance to colleagues and receives guidance from Associate Director

In addition, this position will be accountable for the following (but not limited to) activities:  review and approval of validation/qualification documentation, batch record review, support for internal/external audits , inspection readiness management, execution of complaint investigations, approve investigations, Annual Product Reviews, regulatory document reviews, process change request activities, SOP development and review, execution of environmental sampling, and other Quality Assurance related functions as assigned.

Primary Responsibilities

Delivery

• Performs, interprets, reviews, and approves equipment/process validation/qualification activities. Provides review and approval of change control documents
• Performs and coordinates in-depth system based, process and pre-PAI audits as it relates to compliance concerns and conveys and manages any resulting corrective action plan
• Performs incoming material, bulk, and finished product release activities to include CBER Release requirements and accepts delegated authority for review and release of materials/documents designated for domestic and international distribution as required
• Manages, tracks, and trends Vendor Quality Reports, and examines report replies and participates with corrective actions
• Accountable for defect resolution and the control of material throughout the plant
• Participated in the completion of significant deviations, field alerts, BPDR’s and investigational activities which span multiple sites, divisions and competencies
• Able to interpret policies, regulations, etc. to determine defect classification and appropriate resolution activities and mentor others on these decisions
• Completes routine complaint, stability, vendor and packaging investigations and recommends disposition of affected material
• Possesses excellent technical writing skills and drives peers and customers to provide robust investigations 
• Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective actions
• Monitors trends and recommends corrective actions to cease continued performance issues
• Able to present data to others outside of working group to gain consensus on appropriate path forward
• Completes Annual Product Reviews and retrieves approval signatures and completes scrutiny of product performance trends
• Provides Quality Assurance review and approval of all GMP-related SOPs
• Develops programs/procedures to improve compliance status of Wilson operations
• Ensures that all SOPs and docu