Associate Director, Quality Assurance

Kincell is seeking a highly motivated Associate Director who will be a key contributor to a dynamic and collaborative Quality Assurance team.

The Associate Director of Quality Assurance is responsible and accountable for all aspects of the Quality Assurance.  Develops, implements, and maintains an effective Quality Management System in accordance with appropriate regulations and standards. 

The Associate Director of Quality Assurance is responsible and accountable for all aspects of the Quality Management System (QMS), and the Product Data Group (PDG). The Associate Director will offer guidance and support to personnel in a cGMP manufacturing environment, either self or through direct reports. Possesses and applies a broad knowledge of Quality principles, practices, and procedures with an astute ability to rank priorities in order of importance and feel comfortable making decisions on quality matters. Manages and supports a variety of processes including Document Control process and Change Control process. Responsible for material and Finished Goods Disposition and Release. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in cGMP sterile manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Supervise staff including hiring, training, evaluating performance, and performance management.
• Ensure all employees have the necessary training, tools, information and materials to properly and safely perform their job responsibilities.
• Oversees and supervises broad areas of operations, such as reviewing QC testing, scheduling of work, provide basic technical and quality support to staff members and clients.
• Assign training and monitor and review training completion to ensure personnel are properly trained and capable of completing their assigned tasks.
• Lead Deviation, CAPA and Change Control, Supplier Quality, Customer Complain Document Control and Audit Management programs.
• Act as the main interface between Kincell Bio Quality and client Quality; ensures the status and progress of projects is on target and easily visible to Kincell Leadership.
• Demonstrated attention to detail and ALCOA standards implementation.
• Participate in writing, reviewing and approving Standard Operating Procedures, Reports, etc.
• Overseeing or reviewing, completing and processing of process documentation.
• Oversee budgets and goals for the group on an annual basis.
• Supervise and guide internal and external audits of various departments/processes.
• Oversee and perform QA activities, including processing change requests, manufacturing records, and other documents.
• Assist with developing or participating in department or cross-functional project or program objectives, which include proposed budgets, timelines, materials, personnel and other project requirements, receives direction and presents information updates to leadership.
• Assures Kincell is compliant with regulatory expectations.
• Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
• Addresses audit observations or recommendations and implement corrective/preventive actions as needed.
• Serve as the lead auditor for client inspections.
• Preparation, execution and maintenance of quality agreements.
• Ensure compliance with GMP, EU, FDA, OSHA, and all other regulatory requirements in accordance with company policy.
• Adhere to company safety requirements. Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
• Other duties as assigned.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

Required:

• BS required, MS preferred in a scientific/technical discipline with 8+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry.
• Experience with writing Deviations, CAPAs, Change Controls, Audit Responses, Lab investigations and OOS required.
• Supervising and evaluating employees and providing related recommendations
• Training others in policies and procedures related to the work
• Serving as a team member in developing and managing projects.
• Operating in both a team and individual contributor environment.
• Preparing very complex to specialized function reports, correspondence and other written materials.
• Using independent judgment within established department guidelines.
• Using tact, discretion and prudence in working with those contacted in the course of work.
• Performing effective oral presentation to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with a variety of individuals.
• Experience with regulatory inspections from the FDA, EU, Health Canada, or other regulatory authorities.
• Solid knowledge of FDA and EU regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Ability to write reports, business correspondence, and procedure manuals.
• Able to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
• Ability to effectively present information to employees, peers and Company Leadership.
• Must be able to assess and utilize software and customized programs to meet QC business needs
• Strong interpersonal, communication and leadership skills is required.

Preferred:

• 2 years CDMO experience
• CQA certification
• Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS)

   Physical Demands

• Adjusting or moving objects weighing up to 25lbs

 Travel Requirements

• N/A

 Location

• This is a site-based position located in RTP, NC and it will require some non-standard working hours, including early morning or late evening.

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