14 September 2022
Director of Quality-Pharmaceuticals

Director of Quality
OTC Manufacturer
Miami Lakes Area 
4 direct reports 
 
Our client is a manufacturer of OTC and cosmeceuticals products located in North Dade County and has engaged ttg Talent Solutions to find their next Director of Quality.
 
Overview
As the Director of Quality for our Miami Manufacturing Plant, you will lead the Quality team to ensure compliance with FDA regulations and customer expectations. You will manage the daily QC/QA operations for OTC drugs and cosmetic products to ensure continuous quality improvement and product quality. Together with the Operations team, you will ensure a culture of compliance through the manufacturing, packaging, laboratory, and warehouse areas. The position reports to the VP of Quality and Regulatory and has 4 direct reports (a total of 20).

Requirements
  • BS. in Chemistry or related Science with progressively responsible experience in Pharmaceutical Quality Management.
  • Must have 5 years of experience in QC, QA and Regulatory in a Pharmaceutical environment with 5 years of experience in a leadership role in any industry
  • Must have experience managing a team
  • Proficient in analytical chemistry and HPLC Method Development, troubleshooting and Validation.
  • Excellent technical writing, analytical and problem-solving skills
  • Understanding of FDA’s and CGMP requirements.
  • Experience in authoring, reviewing, and /or approving CGMP-related documents (investigations, validation/qualification reports, STPs, SOPs and protocols).
  • Bilingual preferred – English/ Spanish
Responsibilities include:
  • Supervise and provide technical guidance for the QC and QA operations and personnel.
  • Ensure QC and QA support to Planning and Operations for timely release of products and materials.
  • Train and provide hands-on support to laboratory staff in analytical testing methodologies and equipment, perform technical and compliance reviews of analytical data and coordinate and/or perform analytical equipment qualification and calibration activities.
  • Ensure all analytical methods are appropriately validated, and micro, stability, data integrity and environmental monitoring programs adhere to current regulatory expectations. Ensure manufacturing equipment and utilities are adequately qualified or validated.
  • Provide quality oversight of manufacturing, packaging and warehousing operations.
  • Performs and writes robust laboratory and manufacturing investigations to ensure adequate root cause analysis is performed. Assure investigations and CAPAs are handled in a timely manner and CAPAs are checked for effectiveness.
  • Assure systems are in place and functioning properly to meet CGMP requirements.
  • Manages the Training and Validation programs.
  • Prepare, review and/or approve validation and qualification protocols, reports, SOPs, and Test Methods.
Compensation
Salary $100K-$150K ( KPI Bonus - to be determined) plus medical benefits, Dental, vision and more, plus PTO and a 401(k) matching
 
Apply
Please submit your updated resume in a word document.
At this time we are only considering local candidates, however, if you are already planning on being in the South Florida area, we encourage you to apply. Just let us know when and where you are planning on residing!
 
At ttg, "We believe in making a difference One Person at a Time," ttg OPT