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Senior Manager Product Quality (f/m)

Naturwissenschaften, Ingenieurwissenschaften, Führungskräfte - Pharma - Unbefristet - Vollzeit

Senior Manager Product Quality (f/m)

Primary Function I Primary Goals I Objectives:

 

Senior Manager, Product QA is responsible for quality of Humira biologics drug product, combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional and corporate policies and external agency regulations.  Quality responsibility includes products produced at AbbVie plants and by third party manufacturers (TPM's), including active pharmaceutical ingredients (APIs), sterile finished goods (FGs), as well as quality oversight over the entire supply chain.  Provides strategic and functional leadership of all quality assurance activities related to product and support AbbVie's Third Party Manufacturing. 

Primary responsible for Humira Drug Product manufacture at AbbVie's TPM, including product transfers and projects.

Maintains the primary quality lead for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. The incumbent is the primary driver for the quality and compliance aspects for product transfers and organization optimizations. This involves working with cross functional groups (both internally and externally) to determine their business needs to optimize job functions and reduce compliance risk. In order to achieve this, the incumbent must recognize priorities, dependencies, and critical paths that are important to the sequencing of project activities. This includes anticipating issues as the project progresses and solving these problems quickly, effectively, and cost-efficiently.

Major Responsibilities:

  • Participates in the development of global Product QA strategy to support sterile, biological and/or device third party manufacturing facilities and implements strategy.
  • Functions as main Quality liaison between TPM's and AbbVie Operations in support of commercial operations, new product introductions and product transfers. Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing CMC documents and DMF/CEP documents.
  • Makes key decisions on product quality/compliance and regulatory conformance issues for sterile, biological and/or device products and elevates medium and high risk events to AbbVie management. Performs quality release of manufactured product lots, for products and/or product lines the TPM manufactures.
  • Supports development of the legal supply agreements/contracts/letters of intent to insure the appropriate quality, compliance, and ensures alignment of Quality/Technical Agreements with the legal contracts and that the commitments of the quality/technical agreements are being fulfilled.
  • Establishes and maintains relationships and open communication with TPMs, AbbVie plants, affiliates and other functional groups
  • Possesses knowledge and 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.
  • Coordinates activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and CAPA.
  • Completes management reviews with assigned TPM's that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the TPM to insure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner .

 

Qualifications:

 

  • Bachelor's Degree or equivalent job experience required in relevant Life Science. 
  • knowledge and a comprehensive understanding and experience of biological and sterile aseptic processes.
  • QA Operations Management:  8+ years
  • Operations, R&D,
  • Total Combined Experience: 8+ years

 

We are looking forward to your online application and ask that you state your salary and your earliest start date or notice period in your personal statement.

 

AbbVie is characterized by diversity and internationality. We therefore welcome diversity among our applicants, in particular also chronically ill and severely disabled people.

 

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Mainzer Straße 81
D-65189 Wiesbaden
www.abbvie.com

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