Manager - Quality Assurance

Essential Duties and Responsibilities:

• Develop, implement, and monitor progress against the company's vision, related quality objectives, projects, and goals for department.
• Maintain the corporate training program ensuring that all employees are compliant with the relevant SOPs and internal guidelines.
• Participate in developing, reviewing, and maintaining documents to include corporate level Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Responsible for QA review and approval of change control requests, OOS/OOT investigations, product specifications, in-process controls, and validations.
• Provide QA support for process and product development and be a resource to identify gaps, facilitate remedial actions, and ensure they are resolved in a compliant manner.
• Review, investigate, track, and trend all product quality complaints in an effort to identify quality signals in a timely manner. Prepare reports and report data and trends as required.
• Assist in relevant training to the Quality team.
• Assist in Product Development as it relates to Quality Assurance activity as well as Technology Transfers.
• Establish and maintain compliant quality systems to include SOP, vendor qualification, change control, document control, CAPA, deviations and investigation, complaint handling and internal audits.
• Coordinate quality investigations with suppliers, vendors, contract manufacturers and other third parties. Collect, organize, and summarize data in support of investigation plans as needed.
• Develop and implement process improvements within own area and work effectively with teams to identify and develop process improvements. Participate in other continuous improvement activities.
• Maintain current knowledge of basic requirements for compliance. Interface with Regulatory to ensure good regulatory and clinical practices are met.
• Contribute to ensure compliance of pharmacovigilance activities including activities such as forwarding adverse events and serious adverse events reporting to Pro Pharma, a pharmacovigilance service provider.
• Maintain contact with critical vendors, consultants, and peers to be current with prevailing industry standards.
• Other quality activities, as directed by management.

Leadership & Team Management

• Provide direct people management for assigned Quality team members, including coaching, mentoring, onboarding, and ongoing development.
• Set clear performance expectations, monitor progress, and provide regular feedback, including identification and resolution of performance concerns.
• Support employee development through training, assignments, and career guidance aligned with department and company goals.
• Ensure accurate oversight of timekeeping, attendance, and adherence to company policies and employment compliance requirements.
• Foster a collaborative, compliant, and accountable quality culture within the team.
• Participate in performance reviews, goal setting, and succession planning as applicable.

Cross-Functional & External Leadership

• Provide QA leadership and support for process and product development, technology transfer, and continuous improvement initiatives.
• Coordinate quality investigations with suppliers, vendors, contract manufacturers, and third parties; collect and summarize data as needed.
• Maintain professional relationships with key vendors, consultants, and industry peers to stay current with regulatory and quality expectations

Knowledge, Skills & Abilities:

• Bachelor's degree in a scientific discipline.
• 4-10 years of related work experience in quality assurance/quality control working in a cGMP setting as applicable to the pharmaceutical, OTC and cosmetic environment.
• Strong knowledge of current Good Manufacturing Practices for pharmaceuticals, OTC, and cosmetics
• Working knowledge of global cosmetic and drug regulations including Food, Drug and Cosmetic Act, 21 CFR 210 and 211 Good Manufacturing Practices, and 21 CFR 11.
• Strong interpersonal, communication and organizational skills.
• Proficiency in Word, Excel, PowerPoint, Outlook
• Demonstrate sound technical, interpersonal and problem-solving decision-making skills
• Ability to convey information in a clear, focused and concise manner at all levels with cross functional departments.
• Self-motivated with a collaborative attitude and a desire to continuously learn

Work Environment:
The work environment is indoors in a professional office environment. The floor surfaces are carpeted in office areas and conference rooms with vinyl floor covering typical in hallways, break rooms and computer rooms.

Work Hours:

The work schedule is 5 days per week, 8 hours per day. Initial start time may vary, with work hours typically from 8am-5pm. Work hours and shifts are subject to change depending on operating business conditions and needs. The position resides in Orange County but is hybrid with 2 days being remote work.

Physical and Mental Demands:
Sedentary, exerting up to 10 pounds of force occasionally, or negligible amounts of force frequently, to move objects. This…