Bausch Health

  • Director, Quality

    Job Location US-SC-Greenville
    Job ID
    11208
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The site Quality leader is the Management Representative for the site, and has direct responsibility for the site Quality system and leadership of the site Quality organization. He/She will ensure that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, ISO 13485 standards,  Bausch & Lomb Global Quality requirements and applicable country regulations, (i.e. Brazil, Canada, Japan, Australia, etc.) .  He/She is a member of the site leadership team and, in partnership with the site operations leader, will sponsor a Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations. Directs all technical and GMP aspects of plant activities. Interfaces with other top management personnel to set policy and to assure adherence to these, in addition to governmental standards. Responsible for the decision on acceptability and release of all Greenville products.

    Responsibilities

    Establishes and maintains a site Quality system, which allows for the timely supply of goods and which meets Bausch & Lomb and legal requirements, that is compliant with the B+L Quality Policy.

     

    Areas of focus include, but are not limited to: Laboratory operations (chemistry and microbiology), Production and Process Control, Lot release, CAPA system, Deviation Management system, GMP documentation, Complaint Investigation, Change Management, Supplier quality system, implementation of Global Quality systems and requirements, GMP and ISO 13485 training. Includes establishing and maintaining an overall site Quality plan, the design and tracking of Quality metrics, and providing reports to Global Quality management.

     

    Leads and oversees all Quality and Compliance functions for the Greenville manufacturing site, including preparation and maintenance of the site Quality budget and development of Quality personnel.

     

    Implement and maintain policies and procedures for both internal and contract manufacturing processes. Review and approve site Standard Operating Procedures, ensuring their conformance with the applicable US and other country regulations, ISO standards, and Bausch + Lomb requirements.

     

    As a member of the site leadership team, is the on-site expert on Quality and Compliance, and will provide input and support for the Global Quality Strategies.

    Will be an effective business partner and establish and maintain effective cross-functional relationships with other support functions, as required: site Operations leadership, site engineering, EH&S. Includes effective relationships with global functions: Global Operations and Engineering, Global Regulatory, R&D Leadership.   

     

    Scope of Position:

    The site Quality leader has direct responsibility for the site Quality system and leadership of the site Quality organization. He/She will ensure that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, ISO 13485, Bausch & Lomb Global Quality requirements and applicable country regulations (i.e. Brazil, Canada, Japan, Australia, etc.).  He/She is a member of the site leadership team and, in partnership with the site operations leader, will sponsor a Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations. Directs all technical and GMP aspects of plant activities. Interfaces with other top management personnel to set policy and to assure adherence to these, in addition to governmental standards. Responsible for the decision on acceptability and release of all Greenville products.

     

    Organizational responsibilities include site Quality Assurance (Compliance and Quality Systems), site Quality Control (Chemistry and Microbiology), GMP training and documentation, site Supplier Quality, and external audits (regulatory inspections, notified body audits, and customer audits). 

     

    Additional responsibilities include site Quality budget, hiring and development of Quality personnel, and management of the Quality organization (80+ individuals).

     

    Key Relationships:

    Internal relationships cross-functionally with site leadership team. External to the plant, key relationships include Global Quality, Regulatory Affairs, Medical Affairs, and R&D. Liaise with key customers, and external regulatory bodies.

     

    Qualifications

    Education: 

    At a minimum, a bachelor’s degree in biology, microbiology, chemistry, chemical engineering, or related scientific field with at least 10 years in Quality Assurance, Quality systems, Quality management, or Regulatory management experience in the pharmaceutical  and/or aseptic device industries.   An advanced degree in a science-related field or management and/or experience in multi-facility management is desirable.

     

    Experience:

    A minimum of 10 years’ experience with a demonstrated capability and experience for US Class II/Class III medical devices, as well as non-US medical device, regulations and/or 10 years’ experience in the pharmaceutical industry. With sterile manufacturing experience.  Five+ years QA experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies. Five+ years in management, with a proven track record of successful people management and development of personnel

     

    Special Skills:

    In-depth knowledge of applicable regulations and standards, both domestic and international (medical device and drug). Proven technical and problem solving skills and communication skills (verbal and written). Must have excellent organization and time management skills. Must have demonstrated highly developed skills in leadership, negotiation, and influence in order to successfully interface with individuals from scientific, production, regulatory, and executive management backgrounds, to achieve Quality, Compliance, and business goals/objectives.  Must have a thorough understanding of physical investigation techniques, root cause analysis, and statistical methods. Must have in-depth knowledge of aseptic/sterile manufacturing.  Proven track record in operational excellence (e.g. Lean Sigma) is strongly preferred

     

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