Director, Pharmaceutical Quality Assurance

POSTED: April 12, 2017
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time
START DATE: Immediate Availability

DUTIES/RESPONSIBILITIES:

Essential Functions

  • Assure high standards of quality in all aspects of cGMP compliance.
  • Foster a culture of continuous improvement in all aspects of GMP quality, including the development and administration of policies and practices, which address quality issues throughout the organization.
  • Identify relevant compliance requirements that relate to validation, manufacturing, and product testing and provide current information regarding regulatory requirements, as well as new developments in industry practice.

Additional Responsibilities

  • Monitor changes in FDA regulations, which pertain to PGC operations on matters relating to clinical and commercial product manufacturing.
  • Direct company GMP-based regulatory and quality audits; serve as PGC representative in manufacturing-based audits with the FDA and other government agencies.
  • Provide guidance and direction regarding manufacturing quality to project teams and develop, implement, maintain, and monitor GMP quality systems, including documentation, training, internal and external audits, change control, investigations, deviations and record review, as well as raw material, intermediate, and finished product release.
  • Assess and revise, as needed, standard operating procedures for GMP quality functions and identify opportunities to streamline processes and systems.
  • Resolve discrepancies and deviations by following best practices and providing necessary regulatory guidance.
  • Develop systems to assure proper documentation of all cGMPs, including test methods, specifications, validation protocols, final reports, change controls, and master batch records.
  • Collaborate with colleagues in planning and use of facilities and equipment, including process validation in accordance with guidelines and industry best practices.
  • Serve as member of the senior manufacturing operations team and advise all levels of management on manufacturing quality practices and issues of concern.
  • Regularly review all QA/QC costs that impact the delivery of products that meet quality standards.
  • Assure that all manufacturing R&D and commercial manufacturing and distribution practices and procedures are in full compliance with applicable regulations in the US.
  • Develop and manage a budget to fulfill a comprehensive GMP quality management plan, including new manufacturing quality initiatives for PGC.
  • Other duties as assigned.

REQUIREMENTS/QUALIFICATIONS:

Knowledge/Skills/Abilities

  • Demonstrated computer skills (Word, Excel, PowerPoint).
  • Demonstrated leadership skills and experience leading a diverse team.
  • Experience in a pharmaceutical manufacturing environment.
  • Proven ability to interact effectively with senior business leaders, service providers, and vendors.
  • Strong knowledge of cGMPs as well as other relevant US and international regulatory requirements.
  • Excellent verbal and written communication skills (one-on-one, small groups, and formal settings).
  • Ability to coordinate work assignments/activities for direct reports.
  • Ability to utilize good judgement and diplomacy.
  • Ability to maintain confidentiality and exercise discretion on operational matters.
  • Strong organizational skills and ability to multi-task.
  • Ability to work in a fast-paced pharmaceutical environment, able to work flexible schedules on a short quick notice.
  • Favorable security and reference checks (DEA/FBI/Criminal).

Education/Experience

  • Bachelor's degree in Pharmacy, Science, or Engineering; advanced degree desirable. 
  • Minimum of ten years of experience in the pharmaceutical industry with some experience at the management level with responsibility for manufacturing/GMP QA/QC.
  • Experience with US FDA and/or international authority GMP inspections is preferred.
  • Broad experience in pharmaceutical GXP is desirable.
  • Hands-on experience with ISO quality standards and demonstrated success in project management and process improvement initiatives in the development and manufacture of pharmaceuticals.

APPLICATION INSTRUCTIONS: 

Interested candidates, please submit cover letter and resume to humanresources@prf.org

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