Director of Quality Assurance

Malvern, PA

Apply Apply with LinkedIn
Save

Type: Direct-Hire

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 292714

Date Posted: 11/29/2022

Start Date: 11/04/2022

Shortcut: http://jobs.systemoneservices.com/nlUKtC


 

Title:             Director of Quality Assurance (CDMO)

Location:      Malvern, PA

Type:             Direct Hire

The Director of Quality Assurance is responsible for providing technical understanding and communication regarding the execution of the quality management system.
He/she will effectively influence the leadership on strategic direction and tactical implementation of the quality system.
As Director of Quality  - establish the site’s quality objectives, priorities, and roadmap.
Effectively lead and oversee the inspection readiness program. 
Lead and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements.

Supervisory responsibilities providing both administrative and technical leadership to the site.
Serve as the Site Quality Leader. The QA Director lead and manage a team in development and delivery of team objectives and individual quality systems.
Oversee daily work and provides direction on key priorities as needed.
Determine and manage the work agenda and budget for the team.
Provide leadership and direction in managing product-related quality matters, assuring the independence of the quality unit
As Director of Quality Assurance he/she will lead and respond to regulatory agency inspections and inquiries.
Reviews/approve GMP documentation including procedures, training, master production records, technical protocols and reports, change proposals, deviations and corrective/preventive actions. 
 

 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


  • Project Lead Process Chemist

    Malvern, PA

    Title: Project Lead Process Chemist Location: Malvern, Pa Schedule: M-F 8-5pm Type: Permanent/Direct Start date: Immediate Our Client is a growing CDMO. You will join a growing company that has established a solid reputation worldwide. As part of our c...

    Date Posted: 01/17/2023 Recommended

  • Process Chemist II/III

    Malvern, PA

    Title: Process Chemist II/III Location: Malvern, Pa Schedule: M-F 8-5pm Type: Permanent/Direct Start date: Immediate A growing CDMO that has a site dedicated to the development and production of APIs ranging from pre-clinical / clinical to small scale ...

    Date Posted: 01/17/2023 Recommended

  • Operations Supervisor 1st shift

    Malvern, Pennsylvania

    Title: Operations Supervisor Location: Malvern, PA Schedule: Mon-Fri, 6:00 AM – 2:30 PM Type: Contract to Hire Start date: ASAP The Operations Supervisor is responsible for supervising site manufacturing operations, ensuring that all work completed is ...

    Date Posted: 01/11/2023 Recommended

  • Senior Director / Director Analytical Dev & Testing

    Blue Bell, PA

    Title: Senior Director/Director: Analytical Development and Testing Lead Location: Blue Bell, Pa Type: Direct/Permanent Start date: Immediate Our client is a novel Biotech start-up company with a focus on gene editing technology. This role will report ...

    Date Posted: 01/26/2023 Recommended

  • Sr Director, Quality Assurance (Medical Device)

    Allentown, PA

    Title: Sr Director, Quality Assurance (Medical Device) Location: Allentown, PA Type: Direct Start date: Immediate Responsibilities: Responsible for Lead a team of direct and indirect quality functions with accountability for the Medical Device Franchis...

    Date Posted: 01/27/2023 Recommended

  • QA - Batch Record - CAPA Specialist

    Malvern, PA

    Job Title: QA - Batch Record - CAPA Specialist Location: Malvern, PA Position Summary: This position will report directly to the Head of QA. This position will be responsible for significant responsibilities for executing root cause investigations, own...

    Date Posted: 01/22/2023 Recommended

  • Quality Operations Specialist – 2nd Shift

    Malvern, Pennsylvania

    Title: Quality Operations Specialist Location: Malvern, PA Schedule: Monday-Thursday, 2nd Shift: 12pm-10:30pm + weekend OT Type: Contract to Hire Start date: ASAP The role is responsible for the Quality support functions associated with the manufacturi...

    Date Posted: 01/13/2023 Recommended

  • Sr Dir / Dir Manufacturing Sci & Tech Lead

    Blue Bell, PA

    Title: Senior Director/Director, Manufacturing Sciences & Technology Lead Location: Blue Bell, Pa Type: Direct/Permanent Start date: Immediate Our client is a novel Biotech start-up company with a focus on gene editing technology. This role will report...

    Date Posted: 01/27/2023 Recommended

  • Maintenance Leader, Vandergrift

    Vandergrift, PA

    System One is currently looking for a Maintenance Leader for our client's manufacturing facility in Brackenridge, Pennsylvania (suburb of Pittsburgh, PA). Our client's Maintenance Team is highly skilled and is critical to ensuring large industrial equi...

    Date Posted: 12/16/2022 Recommended

  • Research Scientist

    Exton, PA

    Job Title: Research Scientist Assay Development & High-Throughput Screening Location: Exton, PA 19341 Type: 6+month Contract to Hire Shift/Schedule: M-F 8 - 5 Job Description: The Research Scientist (RS)/Sr Research Scientist (SRS) Assay Development an...

    Date Posted: 12/28/2022 Recommended

  • Director/Sr Director Supply Chain Lead

    Blue Bell, PA

    Title: Senior Director/Director Clinical Supply Chain Location: Blue Bell, PA Type: Direct Hire Startup Biotech Company is seeking a seasoned Clinical Supply Chain Leader to join their team! Responsibilities: Manage and support the life cycle of discov...

    Date Posted: 01/30/2023 Recommended

  • Shift Supervisor

    Vandergrift, PA

    System One is currently seeking experienced Maintenance Shift Supervisors at our client's finishing plant located in Vandergrift, PA. These positions are responsible for leading a diverse, represented hourly workforce in day-to-day problem solving and ...

    Date Posted: 12/16/2022 Recommended

  • Associate Director, Data Standards

    Yardley, PA

    Type: Direct Job Title: Associate Director, Data Standards Salary range: $200-$225K range 100% remote Defines and implements core company, sponsor, and therapeutic area standards for the purpose of increasing efficiency, productivity and quality of del...

    Date Posted: 01/30/2023 Recommended

  • Sr CRA - East

    Blue Bell, PA

    Salary range: 140K - 180K, based on skillset TITLE Senior Clinical Research Associate, Remote, East, US Region LOCATION Fulltime, Remote – will cove PA - idell and east coast of Canada POSITION SUMMARY The Clinical Research Associate (CRA)/Senior CRA?w...

    Date Posted: 01/25/2023 Recommended

  • Senior CRA - West Region

    Blue Bell, PA

    Salary range: 140K - 180K, based on skillset TITLE Senior Clinical Research Associate, Remote, West, US Region LOCATION Fulltime, Remote – will cover CO, TX, UT, OR, CA, and west coast of Canada POSITION SUMMARY The Clinical Research Associate (CRA)/Se...

    Date Posted: 01/25/2023 Recommended