Senior Manager, Lab Systems and Operations (Remote)

Lensa; Irvine (CA); Remote; USD 100,000 - 140,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Manager for Lab Systems and Operations. This role focuses on maintaining high-quality standards for various products while ensuring compliance with regulations. The successful candidate will contribute to strategic decisions and build lasting relationships with third-party manufacturers within a dynamic and innovative environment.

Qualifications

• Minimum 8+ years experience in Quality Assurance Operations Management.
• Direct Manufacturing Plant experience is preferred.
• Strong background in quality assurance/control and regulatory requirements.

Responsibilities

• Responsible for quality of assigned products including pharmaceuticals and medical devices.
• Leads product quality assurance strategy and manages compliance issues.
• Establishes relationships with Third Party Manufacturers to ensure quality.

Skills

Analytical skills

Problem resolution

Interpersonal skills

Education

Bachelor’s Degree in relevant Life Science or Engineering

Job description

Senior Manager, Lab Systems and Operations (Remote)

Senior Manager, Lab Systems and Operations (Remote)

2 days ago Be among the first 25 applicants

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Company Description

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 strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

Purpose

Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, 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 worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.

Responsibilities

• Maintains the primary quality lead with management oversight for project Quality 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, risk management, and compliance aspects of product transfers and organization optimization.
• Leads the development of global Product 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 strategy.
• Makes 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 are not.
• 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. Primary quality contact with Supply Chain and R&D for new products to be manufactured at TPMs. Acts as a resource for TPMs to evalua
• 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 priorities.
• Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. Drives implementation of the Product Transfer Process from R&D to AbbVie sites.
• Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups (R&D, S&T, Site Tech Ops) to determine root cause and implement appropriate actions.
• Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals as required and maintains departmental spend within budget.
• 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. Eur. Documents. Work with AbbVie Affiliates and Regulatory to prepare submissions and participate on emergency response team for all incoming submission deficiencies and questions.
  
  

Qualifications

• Bachelor’s Degree in relevant Life Science, Engineering, or other technical discipline required. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum 8+ years. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting. Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred.
• Knowledge and a comprehensive understanding/expertise 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 ingredients).
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
• Experience with FDA and other regulatory agency interactions and inspections is required.
• Familiarity with the requirements for third party external manufacturing.
• 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.
  
  

Key Stakeholders

External Manufacturing Business Relationships, Operations, Third Party

Manufacturers Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, Research and Development.

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.

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

If you have questions about this posting, please contact [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  IT Services and IT Consulting

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