Manager, QA
Manager, QA
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Job Description
Purpose
Describe the primary goals objectives or functions or outputs of this position.
The Affiliate QA Manager is responsible for providing leadership and oversight of Quality Compliance matters at the commercial entity in support of quality system requirements associated with: pharmaceutical products medical devices combination products and biologics. Specific areas include Storage and Distribution Product Complaints potential quality events/product shortage execution Supplier Controls Product Quality Review Risk Management Agency inspections/internal audits CAPA and overall Quality Manual requirements. This position will ensure that all product process or system related quality activities supporting the business from receipt through shipment of final product are in compliance with Corporate governmental and local regulations.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Responsible for the integration and support of quality regulations: drug biologics device and/or combination products driving the design of effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Responsible for the management and oversight of a team as applicable including hiring setting performance expectations providing performance feedback development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs. In the case of some affiliates the role may not include direct reports but is responsible for all Commercial QA activities at the commercial entity.
- Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
- Lead and oversee support activities related to product actions in the affiliate.
- Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.
- Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
- Responsible for partnering and overseeing support activities related to product actions in the affiliate. Oversee coordination and investigation of key quality systems (ie. CAPA product complaints) ensuring KPIs are being met.
- Perform assessments to determine compliance to processes procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting response to observations and tracking of action plans.
- Quality management of supplier qualification program including performance monitoring for key suppliers QTA management and assessments.
- Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments. Represent affiliate QA in regional global and cross functional teams projects and programs as appropriate.
Qualifications :
- Bachelors Degree in Chemistry Pharmacy Biology other technical/scientific area.
- 24 years experience in quality assurance operations regulatory or relevant experience. Some supervisory/management experience preferred.
- Knowledge and familiarity with product process and both internal and external customer requirements and regulations.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device biologics and pharmaceutical products.
- Strong influencing motivational interpersonal and relationship building skills at all levels.
- Excellent written and oral communication skills. Proficiency in English.
- Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
- Strong decision making skills.
- Negotiation skills effective collaboration and ability to anticipate needs and requirements.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs Attache and Attache Pro.
Key Stakeholders
Local Affiliate functions Commercial QA team Regulatory/Competent Authority Suppliers/Service Providers Product Quality Global functions Commercial Quality Systems Manager
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Fulltime
Employment Type
Full-time
