Quality Assurance Manager
Quality Assurance Manager
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Salary Not Disclosed
1 Vacancy
Job Description
The Affiliate Sr. QA Manager is responsible for providing leadership and oversight of Quality Compliance matters at an operational and regulatory complex commercial entity or multiple commercial entities in support of the 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 Lab Controls 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.
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 large team or multiple teams 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.
- 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.
- In addition to the previous responsibilities and in agreement with the local Law as a Sanitary Responsible is responsible to ensure compliance with the Law and other applicable provisions in accordance with local Good Manufacturing Practices and General Health Law as well as attend the verification visits made by the health authorities and authorized third parties responding in a timely manner to any observation and / or requirement requested by the Health Authority.
- As a Sanitary Responsible is responsible for the quality of the product together with the highest authority of the organization and is responsible for ensuring that a Quality Management System is in place.
Qualifications :
Bachelors Degree in Chemistry Pharmacy Biology other technical/scientific area.
Minimum of 10 years experience in quality assurance quality control operations regulatory or relevant experience. Min 5 years Management experience.
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 with staff and at all levels.
Ability to make operational and business decisions with minimal direction.
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.
Negotiation skills effective collaboration and ability to anticipate needs and requirements managing matrix teams.
Strong computer skills and knowledge of enterprise systems such as SolTraqs Attache and Attache Pro.
Knowledge of the Local Sanitary Regulation (Good Manufacturing Practices and Sanitary Regulation as a Sanitary Responsible)
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
