Manager, Quality Assurance
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Manager, Quality Assurance role, will manage and maintain quality management system (QMS) activities. Provide technical review of quality system records. Solve a wide range of issues that impact multiple functions, following cGMP regulations and company standards. Perform assigned tasks and work to achieve company goals and department objectives. Select, develop, and evaluate personnel to ensure the efficient and compliant operation of the function.
- Manage Avid’s QMS including discrepancy reports and corrective and preventive actions (CAPAs); manage team of QS associates responsible for administration of the QMS.
- Author, review, edit, and approve discrepancy reports including, but not limited to, reports for deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.
- Author, review, edit, and approve CAPA records; ensure CAPA records meet procedural and regulatory requirements.
- Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams.
- Maintain a state of inspection readiness; participate in inspection preparation activities.
- Identify, design, and implement continuous improvement projects and solutions to potential procedure, process, and system gaps.
- Independently manage competing priorities with limited instruction.
- Provide assistance to internal and external customers in support of departmental functions.
- Follow company policies and procedures.
- Train personnel and internal customers on relevant quality processes.
- Perform other duties as assigned.
Supervisory Responsibilities:
- Directs activities of functional areas for direct reports.
Minimum Qualifications:
- B.A. or B.S. degree (preferably in Life Science) and 7 years’ experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience, with five years in Quality.
- Preferably a minimum of three years of supervisory/management experience.
- Sound knowledge of cGMPs or equivalent regulations.
- Ability to interpret and relate Quality standards for implementation and review.
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
- Ability to communicate clearly and professionally both in writing and verbally.
- Flexibility in problem solving, providing direction and work hours to meet business objectives.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $107,300 to $123,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.