Description

The Quality, Validation, and Technical Services Manager is responsible for leading all validation, technical services, and quality engineering functions within an OTC drug and cosmetic manufacturing environment. This role oversees authoring, execution, and approval of equipment, utility, facility, and process validation protocols; ensures statistical and scientific rigor in process engineering; manages sampling plans, SPC, and DOE; and owns the site calibration program, including timeliness and out‑of‑tolerance investigations. Additionally, the manager supports core quality operations, ensuring compliance with FDA Pharmaceutical and OTC Drug regulations, 21 CFR 210/211, 21 CFR 201/701/740, ISO 22716, and internal quality systems. This position plays a key role in maintaining product quality, regulatory compliance, and continuous improvement across manufacturing operations. The manager ensures validation and technical areas compliance with FDA OTC regulations, 21 CFR 210/211, ISO 22716, and industry best practices while supporting continuous improvement and operational excellence.

Responsibilities

• Lead all validation activities, including authoring, execution, and approval of equipment, utility, facility, cleaning, and process validation.
• Ensure validation and technical services comply with FDA OTC regulations, cosmetic GMPs, and internal quality standards.
• Provide quality engineering leadership, including statistical analysis, sampling plans, SPC, DOE, and process capability assessments.
• Own the calibration program, ensuring timely calibration, proper documentation, and investigation of out‑of‑tolerance conditions.
• Support quality systems such as CAPA, change control, deviations, and risk assessments.
• Collaborate with Quality Assurance, Operations, Engineering, and R&D to ensure compliant and robust manufacturing processes.
• Maintain validation master plans, lifecycle documentation, and technical risk assessments.
• Support internal and external audits related to validation, calibration, and quality engineering.
• Support technology transfer, process optimization, and scale‑up activities.
• Drive continuous improvement initiatives using scientific and data‑driven methodologies.

Duties

• Author, review, and approve validation protocols (IQ/OQ/PQ), reports, and supporting documentation.
• Execute or oversee execution of validation studies and engineering trials or oversee execution by technical staff or contractors.
• Develop, maintain and update the Validation Master Plan (VMP) and ensure alignment with regulatory expectations.
• Perform statistical analysis for process validation, sampling plans, acceptance criteria and capability.
• Lead DOE studies to optimize processes, reduce variability, and improve robustness.
• Implement and monitor SPC tools to ensure ongoing process control.
• Manage the calibration program, including scheduling, vendor oversight, and record review.
• Conduct investigations for out‑of‑tolerance or out‑of‑calibration events, ensuring root cause analysis and corrective actions.
• Support equipment qualification, utility verification, and facility commissioning.
• Participate in change control reviews to assess validation and quality impact.
• Maintain technical documentation, including URS, FRS, FAT/SAT, and engineering change records.
• Support quality investigations, including deviations, CAPA, and complaint‑related technical assessments.
• Prepare technical summaries, risk assessments, and validation justifications for audits or regulatory inquiries.
• Participate in cross‑functional meetings to support new product introduction and process improvements.

Knowledge

• Strong understanding of Pharmaceutical and/or OTC drug regulations, including 21 CFR 210/211, OTC monographs, or drug listing requirements.
• Knowledge of Cosmetic GMPs, including ISO 22716 and labeling requirements under 21 CFR 201/701/740.
• Expertise in validation principles: equipment qualification, process validation, cleaning validation, and lifecycle management.
• Deep knowledge of statistical quality engineering, including SPC, DOE, sampling plans, and process capability.
• Understanding of calibration systems, metrology principles, and OOT investigation requirements.
• Familiarity with risk‑based approaches such as FMEA, HACCP, and ICH Q9.
• Knowledge of manufacturing processes for pharmaceuticals, OTC topicals, skincare, haircare, and/or cosmetic formulations.
• Understanding of quality systems including CAPA, deviations, change control, and document control.
• Understanding of manufacturing processes for Pharmaceuticals and/or OTC topicals, skincare, haircare, and cosmetic formulations.

Skills and Abilities

• Strong analytical and statistical skills with the ability to interpret complex data.
• Excellent technical writing skills for validation, engineering, and quality documentation.
• Ability to lead cross‑functional teams and manage multiple projects simultaneously.
• Strong problem‑solving skills using scientific and data‑driven approaches.
• Effective communication skills for interacting with auditors, engineers, operators, and leadership.
• High attention to detail and commitment to documentation accuracy.
• Proficiency with statistical software (e.g., Minitab, JMP) and quality management systems.
• Ability to work in a fast‑paced, regulated manufacturing environment.
• Willing to be hands on with equipment and process operation.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field is a must.
• 5+ years of experience in validation, technical services, or quality engineering within pharmaceutical, OTC drug or cosmetic manufacturing.
• Demonstrated experience with equipment, utility, facility, and process validation.
• Experience with DOE, SPC, sampling plans, and statistical analysis.
• Experience managing calibration programs and OOT investigations.
• Familiarity with FDA inspections, customer audits, and regulatory expectations.
• Certifications such as ASQ CQE, CQA, Six Sigma Green/Black Belt, or Validation Professional are a plus.

Work Environment

The Quality, Validation, and Technical Services Manager works primarily in an office environment within an FDA-regulated chemical manufacturing facility. The position requires extensive use of computers, validation software, spreadsheets, databases, and other standard office equipment to develop, review, and maintain validation protocols, reports, procedures, and regulatory documentation.

The role regularly requires interaction with manufacturing, quality, laboratory, maintenance, and regulatory personnel. While the majority of work is performed in an office setting, the Quality, Validation, and Technical Services Manager is expected to spend time in production, warehouse, laboratory, and utility areas to observe processes, support qualification and validation activities, conduct assessments, and verify compliance with established procedures and regulatory requirements.

The manufacturing environment may include exposure to varying temperatures, noise, chemical odors, moving equipment, forklifts, and potentially hazardous chemicals. Appropriate personal protective equipment (PPE) must be worn when entering designated production, warehouse, or laboratory areas. The position may require walking throughout the facility, standing for extended periods during validation activities, and occasional lifting of materials or equipment weighing up to 25 pounds.

Pay: $95,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: In person