Quality Control Director (Pharma manufacturing)

New Jersey

· Strategic more than operational role

· Vendor management / budget management / training / succession planning

· All QC within NJ site

· Come from either Pharma or BioTech realm

· Environmental Monitoring knowledge

· Flow cytometry (FCM) knowledge

· Senior Management experience

• Similar scale experience in previous roles (5 – 6 Direct Reports, c. 40 indirect reports)

Position Summary

This position will report into the Senior Director of Quality responsible for the oversight and management of Quality Control (analytical and microbiological) at the Clinical and Commercial sites in Allendale, NJ. Responsible for managing the laboratories daily activities and continuous improvement initiatives to ensure compliance and client requirements are met. Core responsibilities include, but not limited to, management of resources (human resources and financial resources), data integrity program and external laboratory management. Collaborates with other departments to support organizational and functional strategy. Represents Quality Control in internal and external audits which may include interaction with regulatory health authorities and clients.

Essential Functions and Responsibilities

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  • Ensure production support and cGMP compliance.
  
  
  • Manages laboratory resources (human resources and financial resources). Prepares and tracks budget and CapEx activities, including staff overtime and contractor budgets, within their scope of accountability and responsibility.
  
  
  • Oversee implementation and maintenance of QC functional group standards, instruments, methods, cGMP documents, sample handling, and applicable electronic systems (including LIMs).
  
  
  • Ensure analytical, micro and environmental monitoring programs adhere to current regulatory expectations.
  
  
  • Manage method validation to support technical transfer activities.
  
  
  • Ensure instrumentation is validated appropriately.
  
  
  • Ensure execution of functional group responsibilities within specifications, procedures, and policies and always maintains QC’s cGMP readiness.
  
  
  • Ensure QC support to Planning, Operations, Supply Chain and other department for timely release of the products to the clients.
  
  
  • Actively participates and enforces Policies, SOPs and Safety Policies to ensure departmental compliance with company requirements and minimize laboratory accidents.
  
  
  • Manages robust laboratory investigations (analytical, micro and environmental monitoring OOS/OOT) to ensure root cause analysis and effectiveness checks are performed.
  
  
  • Provides strong leadership and guidance to laboratory operations and personnel.
  
  
  • Determine metrics to monitor lab performance and present these in Management Review meetings.
  
  
  • Conducts performance evaluations for QC laboratory personnel. Develop goals and manage individual development plan for lab employee.
  
  
  • Manages the training and data integrity programs for the laboratories.
  
  
  • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
  
  
  • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
  
  
  • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary.
  
  
  • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling.
  
  
  • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM),
  
  
  
  

Competencies

• Ability to think strategically and tactically (detail-oriented)


• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment


• Analytical and problem-solving skills


• Strong written and oral communication skills


• Meeting management/facilitation skills/teamwork


• Ability to multi-task team is essential


• Flexible and able to adapt to company growth and evolving responsibilities.


• Ability to effectively interface with peer group in the company and work collaboratively to achieve company goals.


• Collaborates with other team members and demonstrates outstanding interpersonal skills.


• Ability to work autonomously in an entrepreneurial, fast paced environment.


• Strong business acumen


• Ability to think strategically and tactically (detail-oriented)


• Flexible and able to adapt to company growth and evolving responsibilities

Supervisory Responsibility

This position requires the management of personnel from Sr. Manager Level and below.

Qualifications

• Bachelor of Science in biological sciences or other relevant field of study. Advanced degree preferred.


• Significant relevant experience of which a good proportion in a Management role overseeing a laboratory environment with applicable clinical or commercial experience. Experience with environmental monitoring and aseptic processing is preferred.


• Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.


• Understanding of quality system applications, including the training, deviations, CAPA management, etc.


• Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)


• Experience in organizing and leading teams.


• Experience participating in health authority inspections and/or client audits.


• Understand requirements pertaining to aseptic manufacture of cellular products.


• Strong understanding of Tech Transfer and Method Validation


• Ability to work effectively with clients in a contract manufacturing environment.


• Familiarity with the product development process for biological products is helpful.


• Ability to recruit, lead and develop a high-performance manufacturing organization.


• Capable to communicate in English


• Strong written and oral communication skills

Working Environment

• Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.


• Must be able to foster and work in a team-oriented environment.


• Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary.


• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.


• Small breakroom available. No on-site cafeteria available.


• The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel