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Director, Quality Assurance Operations

Director, Quality Assurance Operations

Requisition ID 
2018-2336
# of Openings 
1
Job Locations 
US-TX-College Station
Posted Date 
1/30/2018
Category 
Quality Assurance

More information about this job

Overview

Summary:  The Director of QA Operations will be responsible for oversight of QA operations for cGMP manufacturing of monoclonal antibodies and viral products.

The individual will work with Quality leadership, Facilities, Engineering and Validation groups to implement global and site specific Quality and Risk Management principles to ensure patient safety and product quality, while ensuring compliance with US and international GMP regulations and maintaining facilities inspection ready.

External US

Essential Functions:

  • Leadership
    • Mentors and provides direction to the QA operations organization to ensure organization is complying with site and global quality standards, regulatory requirements and partner commitment.
    • Collaborate across the organization to implement global quality standards to ensure facility inspection readiness
    • Work with Quality management on timing for staffing of QA Operations to achieve on-time drug disposition and maintain site cGMP compliance
  • Operational Delivery
    • Collaborate with site leadership and QA Compliance to develop and maintain a risk based strategic Quality and Compliance plan for the FDBT facilities that will meet US and EU requirements for cGMP manufacturing of drug substance and sterile drug product
    • Oversee on-time and release of assets for GMP manufacturing
  • New Business Growth
    • Support due diligence audits
    • Support client person-in-plant
  • Compliance
    • Review and/or approve basic and complex technical documents, including but not limited to:

Standard Operating Procedures

User Requirements

Change Controls

Deviation and Investigation reports

Process and Facility Trending reports

Annual Product reports

  • Work with Quality management to implement and grow phase appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
  • Support internal quality audits
  • Provide daily guidance for the compliance of Facility with international standards and regulations for GMP manufacturing
  • Support Regulatory, client, and internal audits
  • Act as a QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups as requested
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect the Regulatory Compliance of the facility or of related product quality Provide leadership to the QA team
  • Assist with compliance related functions
  • All other duties as assigned.

Required Skills & Abilities:

  • Ability and desire to learn and undertake additional leadership responsibilities across all Quality Assurance functions
  • Understand manufacturing processes that are placed in the facilities
  • Proven experience supporting the buildout and qualification of a manufacturing facility
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills
  • Ability to set personal performance goals and provide input to departmental objective
  • Ability to multitask and easily prioritize your work
  • Ability to work independently with little supervision
  • Proficient in Microsoft Excel, Word and PowerPoint
  • All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged standing, some bending, stooping, and stretching
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
  • Vision correctable to 20/20
  • Attendance is mandatory

Qualifications:

  • BS or equivalent with 6+ years of Quality experience in a regulated pharmaceutical, biotechnology or supporting CMO environment.  Experience in designing and bringing online new biotechnology manufacturing facilities.  Strong knowledge of US and European compliance requirements.  Strong knowledge of facility engineering and commissioning, biotechnology manufacturing, utility commissioning, regulatory approval process and requirements.  Direct experience hosting or supporting Regulatory agency site inspections.

Preferred Qualifications:

  • Certified Quality Engineer