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Director of Quality

Company: PL Developments LLC
Location: Piedmont
Posted on: April 9, 2021

Job Description:

  • Bachelor's degree in Engineering, Science or Quality
  • 10+ years experience in a leadership role in the pharmacuetical industry
  • Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210, 211 and Part 11 Compliance
  • Working knowledge of ICH Q9 entitled "Quality Risk Management" published in June 2006 and ICH Q10 entitled "Pharmaceutical Quality Systems" published in April 2009
  • Knowledge of OSHA
  • Proficient in Microsoft Office
  • Proven track record with continuous improvement intiatives and successful CAPA implementation
  • Skilled at investigating deviations and exceptions
  • Possess strong analytical and problem solving skills
  • Experience with QC Laboratories and OOS Investigations
  • Must be able to interface positively with Regulatory Agencies, Auditors, Vendors, Customers and Company departments
  • Experience in Oracle system including Agile PQM
  • Strong interpersonal and written and verbal communication skills
  • Experience Leading and Managing Quality Teams POSITION RESPONSIBILITIES:
    • Oversees Quality and Quality Control at the Greenville, SC facility with QA oversite of Rogue operation, Delta lines, GoJo lines, electrolyte suite and other OTC liquid products transferred to OGR
    • Assures product integrity and compliance to cGMP's and in-house SOP's through daily monitoring of operations
    • Maintains product quality by enforcing PLD quality assurance policies and procedures and FDA requirements; collaborating with other cross functional team members to develop process improvements and maintain quality metrics for the Greenville Site.
    • Directs team to prepare product and process quality reports (such as Annual Product Reviews, Deviation Investigations, CAPA Effectiveness, etc) by collecting, analyzing, and summarizing information and trends.
    • Manage team that reviews daily line operations to assure compliance with manufacturing batch records, cGMP's and SOP's
    • Lead Greenville, SC Site QA & QC leadership team
    • Review all IQ/OQ/PQ documents
    • Reviews SOP's periodically
    • Approves Non-Conforming Material Reports and tracks NCMRs in-process
    • Manage the training of all site Quality and Quality Control personnel on current SOP's and work with the Corporate Training Department to coordinate annual cGMP Training.
    • Accountable that all training for the Greenville Site is executed in a timely manner and properly documented in OLM.
    • Maintains and develops Greenville quality assurance and quality control team by recruiting, coaching, training and disciplining employees; establish SMART goals & objectives, monitor outcomes and target dates, and appraising job results
    • Participates in product complaint investigations and CAPA as required
    • Develop talent in the quality assurance and quality control area for future leadership roles in PLD
    • Participate as a member of the PLD Corporate Quality Team focused on continuous improvement, compliance and customer needs (both internal and external)

Keywords: PL Developments LLC, San Francisco , Director of Quality, Executive , Piedmont, California

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