Director, Manufacturing QA

AbbVie•Waco, TX

13d•$160,500 - $305,000•Onsite

About The Position

Responsible for overall quality of AbbVie products including small molecule pharmaceuticals and/or biologics, combination products, and medical devices—complying with delivery time objectives; local, divisional, and corporate policies; and ext. agency regulations worldwide. Scope of responsibility can also include business processes supporting new product introduction, product monitoring, or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), produced by AbbVie or third-party manufacturer Intermediates/Drug Products. Acts as the principle, quality, global supply chain rep. with external manufacturing businesses. Builds and maintains relationships with TPM Operations, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to align strategic initiatives. Develop regulatory strategies for brands with Regulatory Affairs.

Requirements

Bachelor’s Degree in relevant Life Science, Pharmacy, or Engineering is required.
Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
Total combined years of experience 15+ years.
In the pharmaceutical, biologics, device, or chemical industry—a minimum of 5 years of experience in Manufacturing and 4 years of experience in QA, R&D, and/or S&T.
Minimum of 6 years Management and Supervision experience.
Minimum of 5 years’ experience in a direct Plant pharmaceutical setting role.
Required regulatory inspection experience with direct interaction with regulatory inspectors.
Expert knowledge and a comprehensive understanding of 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).
Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, positive interpersonal skills, ability to manage multiple complex tasks simultaneously.
Capable of analyzing data facts and informed opinion to direct the development of effective action plans as well as the ability to problem solve without the benefit of precedent.
The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
Strong leadership skills required to manage professional staff and effectively interface with senior leaders both internally as well as with external organizations.
Capacity to perform as a leader, team member, and individual.
Experience with the requirements for third party external manufacturing.

Nice To Haves

Graduate degree preferred.

Responsibilities

Develop and lead a quality professional team responsible for assigned products’ transfer activities and end-to-end product quality—conforming to worldwide standards/regulations throughout the NPI supply chain & departmental budget.
Lead Product Quality Assurance Transfer Mngr.s to develop strong relationships with Third Party Manufacturers, AbbVie plants, affiliates, & other functional groups.
Help them understand each project’s quality, compliance, & org. resource needs; & align roles and responsibilities.
Ensure delivery of all quality 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 manufacturing, packaging and/or testing.
Core team member or strategic programs lead; including Pipeline Teams, New Product Introductions, Governance Process, CMC Leadership Team, Product Transfers, Specification Approval Team, Regulatory Starting Material Core Team, Global Strategic Sourcing, Due Diligence, and Site Selection.
Make primary decisions on product quality, compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management.
Develop and implement a global Product Quality Assurance strategy to support quality systems or product requirements associated with pharmaceuticals, biologics, devices and combination products manufactured at AbbVie plants or third party manufacturing (TPM) facilities.
Provide a Quality Assurance perspective during new product development and address resolution of quality and compliance issues.
Support development of the legal supply agreements, contracts and letters of intent to ensure the appropriate quality, compliance, and regulatory aspects are met for the products and services covered.
Manage and approve organizations actions—like Quality and Technical agreements— as a representative of AbbVie, within the legal boundaries of these documents.
Approves negotiated quality and technical agreement as a representative of AbbVie.
Key decision maker on product quality, compliance, and regulatory conformance issues for sterile, biological, liquid, solids and/or device products.
Complete management reviews with assigned TPMs that identify and address quality, operational, and organizational issues.
Interface 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.
Provide support for quality audits, initial site approvals and due diligence activities.
Direct and manage pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
Actively participates and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections.
Function as main Quality liaison between Third Party Manufacturers (TPMs) and AbbVie Operations in support of commercial operations, new product introductions, and product transfers.
Negotiates with external companies’ upper management 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.
Establish and maintain relationships and open communication with Third Party Manufacturers (TPMs), AbbVie plants, affiliates and other functional groups (R&D, Regulatory, Purchasing, etc.) to define roles and responsibilities and identify potential projects and issues.
Obtain an in-depth understanding of the quality, compliance, and resource needs at each transfer site.
Provide quality oversight and guidance for successful validations (processes, test methods, etc.) and qualifications.
Communicate and negotiate with the TPM’s 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.
Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.