Director, Quality Assurance - Facilities and Compliance

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. 

Position Summary:

This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, and facilities. Provide quality oversight of facility upgrades and expansions. This individual is responsible for managing the change control system. Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members. Align QA organization to meet companies’ strategic goals.

Responsibilities:

• Provide quality oversight into the Engineering and Validation programs supporting both clinical and commercial operations in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, facilities, cleaning and process validation. Review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program.      

• Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.

• Manages the change control system. Works directly with functional areas to review and approve change controls. Works to continuously improve and streamline the change control system.             

• Providing guidance to QA staff on cGMP requirements for validation, facility, utility, production, equipment and computer systems. Subject matter expert accountable for site level compliance of engineering and validation of cGMP systems to the requirements of US and International regulatory agencies. Assess on an on-going basis the changing regulatory environment to establish policy, procedures and processes that drive continued cGMP compliance and business success. Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in formulating inspection responses.       

• In conjunction with the Engineering, Validation and IT teams, develop and manage all qualification and validation policies, procedures, and protocols.       

Requirements: 

• BS and 12+ year experience or MS and 10+ years’ experience in a QA or GMP environment or equivalent.

• Experience in a QA role supporting validation, engineering, IT and change control required.

• Experience managing a QA organization for both clinical and commercial operations is beneficial.

• Previous experience in validation or engineering is required.

Language Ability

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

Basic math skills are required. Ability to apply concepts of basic algebra and statistics

Physical Demands

Sitting for long periods of time at a computer. Push and pull up to 30 lbs.

Computer Skills

Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, quality management electronic systems

Salary Range: $173,000 - $238,700/yr.

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and