Manager - Quality Assurance

Manager - Quality Assurance

Job Category: Quality Assurance

Full-Time

Hybrid

Irvine, CA 92618, USA

Pay or shift range: $90,000 USD to $100,000 USD The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Description

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 ProPharma, 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 job also requires constant sitting. Constant use of the upper extremities is required to reach, handle, and position tools and equipment. The employee must know and follow proper safety protocols and maintain a professional and polished appearance.

Supervisory Responsibilities: 1-2 Direct Reports

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.