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Senior Manager, QC CMC

伍斯特, 麻薩諸塞州 职位 ID 2203370 类别 Quality Assurance 部门 AbbVie

Description

The Senior Manager, Quality provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include QC-CMC, Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for regulatory submission authoring, compliance and quality oversight for the plant and/or strategic initiatives. Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.

Responsibility:

  • Prepare QC related submission sections for IND and BLA submission. Overy see timely availability data and influence cross function team to acquire required data for submissions.
  • Oversee stability and reference standard programs for clinical and commercials project. Analyze release and stability data to establish specifications and shelf life. Author protocols, specification justifications, stability assessment reports, change controls and other quality documents.
  • Represents site and participates in meetings with CMC, global regulatory team and clients for clinical and commercial regulatory submissions relates strategic planning. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Responsible for various aspects of quality control and quality assurance related to products produced at the plant. This will be at a large plant with high volume, high level of product complexity including multiple products at the site and have the complexity of multiple types of production and testing (Biologics intermediates, drug substances, drug products etc)
  • Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.
  • Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants. Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
Qualifications:

Qualifications 

  • Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master’s Degree or PhD preferred.
  • Certified Quality Engineer or formal training in quality engineering or statistics is preferred
  • 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
  • 4+ years of supervisory/technical leadership experience
  • Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
  • Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
  • Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
  • Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
  • Strong communication Skills, both oral and written
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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