SanFranRecruiter Since 2001
the smart solution for San Francisco jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Commercial Refrigeration Tech(1-ROGER) - Must Meet I-9 Requirements - W-2 Only - No Pay R
Description: This Commercial Refrigeration Tech 1-ROGER Position Features: br Must Meet I-9 Requirements - W-2 Only - No Pay R br S ability To Diagnose And Repair All Commercial Ki br S ability To
Location: Santa Cruz
Posted on: 04/22/2021

Director of Loan Operations
Description: United Business Bank is looking for an experienced Director of Loan OperationsPOSITION PURPOSEThe Director of Loan Operations is responsible for the efficient, effective and accurate performance of all (more...)
Company: United Business Bank
Location: Walnut Creek
Posted on: 04/22/2021

ADAS/AD Domain Controller Product Manager
Description: Job DescriptionLeading the future of luxury mobility Lucid's mission is to inspire the adoption of sustainable energy by creating the most captivating luxury electric vehicles, centered around the human (more...)
Company: Lucid Motors
Location: Newark
Posted on: 04/22/2021

Director Electrical Sales
Description: Make a difference.This director-level leadership role will be responsible for driving the sales and gross margin growth across the state of California primarily within the electrical contractor space. (more...)
Company: Graybar
Location: Dublin
Posted on: 04/22/2021

Satellite Healthcare: Clinic Nurse Manager
Description: The Center Manager role coordinates the care and quality of treatments for patients so they can have life, but also a quality of living. The leader in this role conducts proactive planning and creates (more...)
Company: Satellite Healthcare
Location: Rohnert Park
Posted on: 04/22/2021

Description: Want to join a fast paced, fun, high energy team, looking for a great Graphic Design Manager If so, we'd like to talk with you. Staffing Industry Analysts is a research and advisory firm dedicated to (more...)
Company: Staffing Industry Analysts
Location: San Bruno
Posted on: 04/22/2021

Sr. Systems Manager (NetSuite)
Description: WORLD CENTRIC is looking for a Senior Business System Analyst to be part of our technology team and accelerate the business processes transformation in the areas of Order to Cash, Procure to Pay, Supply (more...)
Company: World Centric
Location: Rohnert Park
Posted on: 04/22/2021

Physician - Administration - Hospitalist - Hospital Medicine - Hospitalist Medical Director
Description: The Hospitalist Medical Director role will be working in the Hospital Medicine specialty, located in San Ramon Regional Medical Center - HM San Ramon, CA. Please contact Charles Collier at for additional (more...)
Company: Envision Physician Services
Location: San Ramon
Posted on: 04/22/2021

Sales Manager
Description: OverviewAs a Sales Manager at Heller Jewelers your primary focus is to manage and oversee sales for the company.--relationships with our customers. You are the most critical link in ensuring that our (more...)
Company: Heller Jewelers
Location: San Ramon
Posted on: 04/22/2021

Operations Manager
Description: Company Overview:We are a rapidly growing e-commerce company making it easy for customers eat more greens by growing superfoods at home.--Hamama empowers anyone to grow healthy, sustainable food at home (more...)
Company: Hamama
Location: West Sacramento
Posted on: 04/22/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Francisco RSS job feeds