Section Manager, Manufacturing Quality Assurance
Posted on: January 15, 2020
- Maintains the primary quality lead with management oversight
for project activities and the team members (within and outside of
AbbVie) to achieve on-time quality deliverables, high customer
value, and profitable results. Primary driver for the quality and
compliance aspects of product transfers and organization
- Participates in the development of global Manufacturing Quality
Assurance strategy to support pharmaceuticals, biologics, device
and combination products produced at AbbVie plants as well as third
party manufacturing (TPM) facilities. Implements agreed
- Performs final quality release of manufactured product lots for
products and/or product lines prepared by AbbVie plants as well as
Third Party Manufacturers.
- Makes recommendations for key decisions on product quality and
compliance and regulatory conformance issues for sterile,
biological, liquid, solids, and/or device products and elevates
medium and high risk events to AbbVie management. Ensures alignment
of Quality and Technical Agreements with the legal contracts and
that the commitments of the quality and technical agreements are
being fulfilled. Helps facilitate resolution in cases where they
- Establishes and maintains relationships and open communication
with Third Party Manufacturers, AbbVie plants, clients, and other
functional groups to maintain roles and responsibilities, identify
potential projects and issues, obtain an in-depth understanding of
the quality, compliance, and resource needs at each site and
provide guidance on quality concerns.
- Communicates and negotiates with external companies' quality
organization to maintain a consistent level of quality and a level
of expectation that will minimize compliance risks but also balance
the cost of operating to provide AbbVie with the agreed service.
Prioritizes programs, initiatives, and problem solving with
consideration for impact to timelines, resources and conflicting
- Provides support for quality audits, initial site approvals and
due diligence activities.
- Contributes to Quality Assurance elements needed to facilitate
new product launches including Client and Third Party
Manufacturer's that provide products to AbbVie domestic and
International plants and client fill finish sites for further
manufacturing and/or testing. Supports the management of exception
documents and Corrective and Preventive Actions.
- Provides information and reviews summaries of the Product
Quality Reviews for products manufactured by AbbVie to ensure
accuracy, completeness, timeliness, and trends are identified and
addressed in an appropriate manner.
- Reviews and provides necessary information for Regulatory
filings and validation protocol/reports .
- Bachelor's Degree in relevant Life Science or other technical
discipline or equivalent job experience required.
- 10+ years of total combined experience within Quality Assurance
or Operations. Direct Quality Assurance experience preferred.
- Knowledge and a comprehensive understanding of some biological
and/or pharmaceutical technologies (sterile, biological, liquid,
ointments, devices, solid tablets and caplets, suspensions,
granulations, soft elastic capsules, gel caps, extended release
products, coating solutions, and/or active pharmaceutical
- Possesses knowledge and a skill set to operate within an
environment that requires a high degree of urgency, strong
analytical and problem solving skills, positive interpersonal
skills, ability to manage multiple complex tasks simultaneously,
and capable of performing as leaders, members and individuals.
- Knowledge and understanding of process validation for
- Direct supervisory require d
Keywords: AbbVie, Worcester , Section Manager, Manufacturing Quality Assurance, Executive , Worcester, Massachusetts
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