Validation & Engineering Group, Inc.

Director of Quality (QA/QC)

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  6 days ago
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Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

  • Director of Quality (QA/QC)



We are seeking an experienced Quality Director to lead and oversee all Quality Assurance and Quality Control functions at a pharmaceutical manufacturing site. This role ensures compliance with cGMP standards, regulatory requirements, and drives a culture of quality, continuous improvement, and operational excellence.

Key Responsibilities:

  • Lead site-wide QA and QC operations, including batch release, testing, validation, and compliance
  • Ensure adherence to FDA and global regulatory standards (cGMP)
  • Oversee audits, inspections, CAPA, deviations, and change control systems
  • Develop and implement quality strategies aligned with business objectives
  • Build, mentor, and lead high-performing quality teams
  • Partner cross-functionally with Manufacturing, Supply Chain, and Regulatory Affairs

Requirements:

  • Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related)
  • 8–10 years of pharmaceutical industry experience in QA/QC, with leadership responsibility
  • Strong knowledge of cGMP, FDA regulations, and quality systems
  • Proven track record managing audits and regulatory inspections
  • Excellent leadership, communication, and decision-making skills

Preferred:

  • Advanced degree (MS, PhD, or MBA)
  • Experience in sterile or solid dose manufacturing environments

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
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