AbbVie
Associate Director, Product Quality
North Chicago, IL, United States · Director
Sponsorship not specifiedDetected 21 hours ago
Operations ManagementSupply ChainCustomer SupportFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingProcurementRegulatory Affairs
About the role
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
- Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships.
Responsibilities
- Lead a team of Quality professionals for product transfer activities and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results.
- Develops Global Product Quality Assurance strategy and implements agreed strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities.
- Primary Quality contact between third party manufacturers, R&D 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 of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph.
- Lead QA contact with AbbVie Affiliates and Regulatory to prepare submissions and partic
- Leads the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local / global project implementation.
- Leads product quality team to support development of the legal supply agreements, contractors or letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and services covered and manage the organisation's actions within the legal boundaries of these documents.
- Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates 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.
- Supports the management of exception documents and CAPA.
- 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.
Requirements
- Bachelor's Degree in relevant Life Science or other technical required.
- Graduate degree desired.
- Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
- Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
Nice to have
- Total combined years of experience.
- Required regulatory inspection experience with direct interaction with regulatory inspectors.
- Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
Benefits
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Company info
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
Equal opportunity
- Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www.abbvie.com/join-us/reasonable-accommodations.html
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.