Director of Validation

Overview

Summary: QC Manager of Drug Product Operations under general direction from the QC Director, will be required to oversee all activities involved with Drug Product Quality Operations.  The Manager is responsible for all aspects of the visual inspection program including 100% inspection, AQL inspections, automated inspections, particulate investigations and identification of required particulates.  The position also requires oversight of all container closure integrity testing activities for component release and final product testing.  These methodologies will also encompass sub-visible particulate testing via USP , USP and USP .  Candidates for this managerial position must have experience in Drug Product visual inspection as well as sub-visible particulates testing in a regulated pharmaceutical and /or biotechnologies setting.  Strong candidates will have a working knowledge of GMP functions and USP guidelines.

Other responsibilities may include but are not limited to staff hiring, supervision, training, discipline and performing annual review assessments. Preparing and reporting out monthly metrics for all worked performed within the department.  Ensuring all equipment is in a state of GMP readiness.  Writing and Reviewing SOPs, verification protocols and reports. 

In the absence of other supervisory staff they will provide guidance to other groups within the QC organization.

Essential Functions:

• Provide clear and understandable direction and goals for the team.
• Interpret applicable quality and regulatory requirements and develop associated policies for the laboratories operations.
• Manage operating costs for the outsourced testing and laboratory supplies.
• Develop and enhance the Company Visual Inspection program. Establish, monitor and investigate Action and Alert limit excursions and implement corrective and preventive actions, as needed.
• Oversee and guide investigations regarding invalid and out-of-specification results.
• Assure the implementation and effectiveness of appropriate and timely corrective actions.
• Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management Team.
• Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
• Interface with current and potential clients.
• Interface with investigators during both internal and external inspections and audits.
• Evaluate external audit observations and develop responses and oversight for related action plans.
• Adapt, develop, or review and approve procedures, protocols and reports.
• Follow and enforce all established laboratory, regulatory, safety, and environmental procedures.
• Adhere and enforce the standards of quality ruled by current GMP and the company Quality Policies and site SOPs.
• Identify and assist in deviation investigations and report possible preventative and corrective actions.
• Knowledge base in USP 790 / 1790 / USP 787 / USP 788/ USP 789
• Familiar with qualification of personnel for visual inspection and perform training and routine in-line audit assessment of personnel performance
• Review and approve associated documentation (Sample Plans, Product Specification)
• Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in (OOS) Out-of-Specification and failure investigations.
• Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis.
• Perform other duties as assigned.

Required Skills & Abilities:

• Follow proper safety measures and policies while working in the lab.
• Develop staff to maximize contributions to team and company.
• Must have excellent organizational, written communications and oral communication skills.
• Ability to explain information appropriately based on the audience (i.e. technical concepts to a non-technical audience).
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Computer proficiency required, Knowledge of MS Office (Word, Excel, Outlook, PowerPoint).
• Detail oriented and accurate.
• Ability to multi-task and prioritize work assignments with little supervision.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Must be willing to work flexible hour, to include weekends, holidays, and night shifts
• Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

Qualifications:

• Master’s degree in Biology, Chemistry, Biochemistry or similar education/experience and 6 years’ GMP experience ;OR
• Bachelor’s degree in Biology, Chemistry, Biochemistry or similar education/experience and 8 years’ GMP experience; OR
• Associate’s Degree in Biology, Chemistry, Biochemistry or similar education/experience and 10 years’ GMP experience

Previous supervisory experience or demonstrated skills to lead and mentor a group cohesively, effectively and with compliance.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.