Sr. Director of Quality Operations & Technology

Job Summary

The Senior Director of Quality Operations and Technology will ensure the company goals are met for product quality, cGMP analytical and microbiological testing as they relate to finished goods, excipients, components and Environmental Monitoring. This position will ensure that Operations follow the cGMP standards required under Sections 503B of the US Food, Drug & Cosmetic Act. The Senior Director of Quality Operations and Technology will provide guidance for improving cGMP processes, laboratory testing processes and Quality Assurance processes for greater compliance with increasingly stringent regulatory expectations. The successful candidate must have demonstrated technical expertise in Analytical Chemistry, Microbiology, FDA cGMP regulations for 503B, USP requirements, State Boards of Pharmacy regulations and have experience in FDA and State Boards of Pharmacy regulatory inspections. The candidate must build and maintain relationships, trust, and respect with subordinates, peers, and leadership.

Position Responsibilities

• Ensure compliance with US Food, Drug & Cosmetic Act, Section 503B, and all cGMP elements related to facilities, utilities, warehousing, production, testing, documentation, training, reports and records.
• Responsible for all QC activities related to, incoming raw materials, in-process raw materials, finished products, process validation, environmental monitoring, root cause analysis, and technical guidance.
• Maintaining quality systems, including but not limited to change control, CAPA, deviations/investigations, product complaints, vendor qualification. Review and approve complex 503B quality systems documentation in multiple technical areas, including SOPs, batch records, protocols, forms, checklists, etc.
• Management external testing laboratory and for out-of-specification results ensuring that all investigations proceed in a logical, orderly and timely manner and that appropriate corrective and preventive actions are identified, when necessary, review and approve investigation reports.

• Oversee operations of the in-house microbiology lab and analytical lab in Nashville.
• Manage implementation and maintenance of Quality Systems following cGMP, including but not limited to, Laboratory Procedures (SOPs), Deviations, Personnel Training, and Policies. Interpret SOPs/Methods/Specifications and provide clarity as needed.
• Support the site Stability program for testing, data analysis, validation, and commercial products. The position will partner with QA to ensure the stability program remains in a state of sustainable compliance.
• Oversee in-house EM program, Sterile Water for Injection still monitoring, Gown Qualification and Media Fill program and recommend changes for highest standards per regulatory requirement.
• Build a plan to bring testing in-house by defining requirements for external testing laboratories to transfer methods.
• Review and sign-off process, method verification/validation reports, and annual product review reports. Review the certificate of analysis to ensure compliance with the specifications.
• Develop and Monitor KPIs to improve department metrics including Tracking and Trending of OOS results, Environmental excursions, and deviations. Provide recommendations for improvements.
• Provide ongoing support for the manufacturing of aseptic drug products.
• Maintain quality systems activities such as metrics, documentation management, risk assessment, etc.
• Participate in internal and external audits including FDA and State Board of Pharmacy
• Ability to manage heavy workloads and aggressive timelines, prioritize, and work under pressure.
• Participate in cross-site communication and information sharing to ensure communication and implementation of industry best practices.
• Support implementation of projects within budgets and project timelines.
• Make decisions and implement solutions where deficiencies are found. Provide formal and informal performance feedback to direct and indirect reports including disciplinary action when necessary.
• Provide input on employee development including promotion and salary increase recommendations.

Qualifications

• Bachelors Degree in Science, Microbiology, Engineering or related field or equivalent work experience required.
• Masters Degree in Science or Business related field preferred.
• 15 years of progressive experience within cGMP quality operations in pharmaceutical industry.
• A minimum of 10 years experience working in Analytical chemistry, using Analytical techniques; previous experience with Environmental monitoring and Microbiology laboratories in a pharmaceutical manufacturing facility; strong knowledge of regulatory, USP and guidelines.
• Must be precise and consistent in laboratory data interpretations concerning USP general chapters and applicable FDA guidance, thorough in reviewing and evaluating laboratory data concerning established specifications.
• Must be able to identify problems during data analysis and participate in troubleshooting of instrument-related and procedure-related problems.
• A comprehensive knowledge of pharmaceutical quality systems, Quality Management Systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices (cGMP).
• Familiarity with pharmaceutical manufacturing process operations, automation, and equipment/facilities validation.
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Strong written, verbal, and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel), must be able to learn additional software as required.
• Ability to work under pressure, meet deadlines, and exercise sound business judgment with critical thinking skills and high ethical standards.

Competencies

1. Communicate Effectively
   2. Challenge the Status Quo
   3.    Influencing
   4.    Demonstrates Ethics and Integrity

Physical Demands

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 accommodation can be made to enable people with disabilities to perform the described essential functions.

While performing the duties of this job, the employee is regularly required to communicate effectively. The ability to see distinctions in colors and shapes is also required. This position is moderately active and requires standing and walking for the duration of the shift. There is a high frequency of reaching over your head and bending down throughout the duration of each shift.

Work Environment

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

This job operates in a health care setting. This position requires frequent standing and walking to storage shelves and filling counters to fill prescriptions. While performing the duties of this role, the employee will be exposed to light, noise. 

• The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch.
• The employee must occasionally lift and/or move up to 50 pounds.
• May work with hazardous materials and chemicals.
• Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
• Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Position Type and Expected Hours of Work

 This is a full-time, Exempt level position. The working days are Monday through Friday in Ledgewood, NJ. This position may allow for some remote flex day opportunities.