Quality Director

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness. Our client, a specialized compounding pharmacy, is seeking an experienced and dedicated quality leader committed to the highest standards of regulatory compliance, product quality, and patient safety for the following direct-hire position: Quality Director

ABOUT THE ROLE

The Quality Director leads the Quality organization and serves as the primary quality authority for a 503B outsourcing facility. This position is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS), ensuring that products are manufactured, tested, released, and distributed in compliance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) standards, state pharmacy requirements, and internal quality policies. The Quality Director provides strategic leadership and oversight across Quality Assurance and Quality Control, including deviation management, CAPA, change control, document control, training, investigations, validation, environmental monitoring, stability programs, supplier qualification, audits, product disposition, and regulatory inspections. The role also oversees Quality Control laboratory activities, including routine testing, method validation and verification, and analytical investigations. Working closely with Operations, Engineering, Supply Chain, Executive Leadership, and other cross-functional teams, the Quality Director establishes and maintains robust quality processes that support product quality, patient safety, and the safe, consistent, and reliable production of compounded drug products. This individual plays a critical role in fostering a strong culture of quality, maintaining regulatory and inspection readiness, driving continuous improvement, and supporting continued business growth. Success in this role requires strong leadership, technical expertise, regulatory knowledge, sound judgment, and the ability to collaborate effectively across functions.

RESPONSIBILITIES

Develop, implement, maintain, and continuously improve the Quality Management System (QMS) supporting 503B outsourcing facility operations. Ensure compliance with FDA cGMP requirements, applicable provisions of the Federal Food, Drug, and Cosmetic Act, USP standards, and state pharmacy regulations. Serve as the primary Quality representative during FDA inspections, client audits, and regulatory assessments. Provide quality oversight for sterile and/or non-sterile compounding operations, including production processes, equipment, facilities, and personnel practices. Establish and maintain quality systems for deviations, investigations, CAPA, change control, document control, training management, complaints, and product quality reviews. Review and approve batch records, laboratory results, investigations, and final product disposition decisions. Oversee Quality Control laboratory activities, including testing requirements, method validation and verification, stability programs, and analytical investigations. Develop and maintain audit programs for internal operations, supplier qualification, and contract testing laboratories. Lead regulatory inspection preparation and maintain ongoing inspection readiness. Provide quality guidance and oversight for facility expansions, equipment qualification, process validation, and technology implementation projects. Establish quality metrics and provide executive leadership with reporting on compliance performance, trends, risks, and improvement opportunities. Foster a strong culture of quality through training, coaching, accountability, and continuous improvement initiatives. Partner with Operations and Manufacturing leadership to identify quality and compliance risks and implement effective mitigation strategies. Lead, mentor, and develop Quality Assurance and Quality Control personnel. Support product complaints, recalls, adverse event investigations, and regulatory reporting activities, as required. Ability to work onsite and support operational needs as required. Occasional travel for regulatory meetings, vendor audits, or industry events may be required.

SKILLS

Strong knowledge of FDA cGMP requirements and regulatory expectations for 503B outsourcing facilities. Knowledge of USP , USP , and applicable pharmacy compounding standards. Experience developing, implementing, and managing a pharmaceutical Quality Management System. Strong understanding of Quality Assurance and Quality Control principles within pharmaceutical manufacturing. Experience with investigations, root cause analysis, CAPA, and change control processes. Ability to interpret and apply FDA regulations, guidance documents, and relevant industry standards. Strong leadership, communication, and interpersonal skills. Ability to collaborate effectively across Manufacturing, Operations, Regulatory, and Executive Leadership teams. Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment. Excellent problem-solving, critical-thinking, and decision-making abilities. Proficiency with electronic Quality Management Systems (eQMS), Microsoft Office Suite, and quality documentation systems. Exceptional attention to detail and a strong commitment to product quality and patient safety.

QUALIFICATIONS

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline. Advanced degree (MS, PharmD, or related discipline) preferred. Minimum of 8–10 years of experience in pharmaceutical quality, Quality Assurance, Quality Control, or regulatory compliance. Minimum of 3–5 years of leadership experience managing Quality teams within pharmaceutical manufacturing, compounding, or another regulated healthcare environment. Direct experience supporting FDA-regulated operations, preferably within a 503B outsourcing facility, sterile compounding facility, or cGMP manufacturing environment. Demonstrated experience supporting and managing regulatory inspections and audit activities. Experience implementing, managing, or improving pharmaceutical quality systems. Experience with aseptic processing, environmental monitoring, sterility assurance, and/or laboratory operations preferred. Experience with validation programs, including equipment qualification, process validation, cleaning validation, and computerized systems validation, preferred. At Pinnaql, 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. #J-18808-Ljbffr Pinnaql, Inc.