The Staffing Resource Group, Inc
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Quality Director
Posted: 10/20/2023
2023-10-20
2024-02-08
Employment Type:
Direct Hire
Division: Life Sciences
Job Number: JN -102023-17746-1
State: Florida
Job Description
Quality Director
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
A global leader and trusted supplier in the pharma, biotech, and specialty ingredients markets. The company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
The Director, Head of Quality Small Molecules is responsible to lead and coordinate all activities related to the Site Quality Unit (quality systems, quality assurance and quality control) and ensure there are appropriate resources available to meet production demands in our Tampa, Florida Solid Oral Dose facility. The current team has 2 direct reports and approx. 45 indirect reports.
Key Accountabilities:
EOE/ADA
IND123
#LI-SRG17
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Location: Tampa, FL (client on-site and not remote)
- Industry: Pharmaceutical
- Hours: M-F, 8am-5pm
- Salary: Competitive within industry
- Employment Type: Direct hire
A global leader and trusted supplier in the pharma, biotech, and specialty ingredients markets. The company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
The Director, Head of Quality Small Molecules is responsible to lead and coordinate all activities related to the Site Quality Unit (quality systems, quality assurance and quality control) and ensure there are appropriate resources available to meet production demands in our Tampa, Florida Solid Oral Dose facility. The current team has 2 direct reports and approx. 45 indirect reports.
Key Accountabilities:
- Lead Quality team responsible for following functions: Quality Assurance, Final Batch Release and Incoming Inspection, Documentation Control, Validation and Production Line Clearance, Continuous improvement on site, Quality Control, Stability programs.
- Assure cGMP and compliance.
- Approval of major and critical deviations.
- Approval of new product introduction.
- Approval of CAPA plans following customer audits and HA inspections.
- Approval and evaluation of the Annual Quality Review.
- Responsible for Data Integrity for Production and QC Equipment (data recording).
- Responsible for keeping Site Master File updated and informing authorities of relevant changes.
- Management of GMP inspections
- Embeds Quality Culture at site.
- Issuing/updating the Quality Policy, in cooperation with leadership team.
- Issuing/updating the Quality Policy, in cooperation with leadership team.
- Manage Quality Budget within the site across QA and QC.
- Develop People within quality and at Site.
- Member of Site Leadership Team and Global Quality Leadership Team for Small Molecules
- Comply with EHS policies and guidelines. Ensure appropriate housekeeping of Quality area, especially QC.
- Drives for results with a high quality of performance and accountability.
- Bachelor of Science or Higher Education in Chemistry, Biochemistry or Pharmacy
- 10+ years in Quality of Manufacturing Operations in a cGMP regulated environment
- 5 - 10 years of managing personnel
- Well versed in leadership capabilities. This site is growing and desire to grow and embrace change.
- Must have oral solid dosage experience
- Must have experience within CDMO/CMO environment and working all departments involved in Operations.
- Experience with SAP, Trackwise preferred
- Experience with both clinical and commercial manufacturing is a plus
EOE/ADA
IND123
#LI-SRG17
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For more than 30 years, SRG4 has worked with clients in Fortune 100 corporations, as well as emerging and rapid growth companies, located throughout the United States and globally.
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