Cosmetics/OTC Manufacturer
On-site in Miami, Florida
Open to relocation assistance for the right candidate
Our client is a manufacturer of OTC and cosmeceuticals products located between Miami and Ft Lauderdale. They have engaged ttg Talent Solutions to find their next Director of Quality- Cosmetics/OTC. They were established over 40 years ago.
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 CEO and has 4 direct reports (a total of 35 ).
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 the 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.
- Understanding of the business from an “Operations” standpoint.
- 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
- Looking for a leader who has the vision to build up the team to create a legacy.
MINIMUM REQUIREMENTS
- BS. in Chemistry or related Science with progressively responsible experience in OTC/Cosmetic Quality Management.
- Must have 5 - 10 years of experience in QA or Operations in a Cosmetic or OTC industry with 5 years of experience in a leadership role in any industry (Could have 5 years in OTC/Cosmetics industry with 5 years in Food related industry)
- Must have experience managing a team
- Knowledge and experience in HPLC method development and validation
- Experience with Quality Management for OTC Drug Products
- Experience with Quality Management for Personal Care Drug Products, Cosmetics, OTC, Supplements or related
- 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 – English/ Spanish helpful, not required
Compensation
Salary $150K ( KPI Bonus TBD) plus medical benefits, Dental, vision, and more, plus PTO and a 401(k) matching
Apply
Please submit your updated resume in a word document. If you are match, you will be contacted by a ttg Talent Solution Recruiter by email/phone. Please monitor your inbox, junk, spam.
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