Associate Director QA (Biotech)

Manage Noven's Investigations, Product Release, Manufacturing Quality Assurance and Receiving Inspections systems.  Assure that these quality systems are maintained in compliance with applicable regulations as well as Company policies and procedures.  Assess opportunities for improving these systems; support, direct and facilitate change efforts.  Manage staff responsible for the Investigation, Product Release and Inspections functions.

Ensure incoming materials/components, work in process and finished goods are dispositioned in a timely manner and are in compliance with internal SOP's, Safety initiatives, Company policies, FDA and DEA regulations.

Responsibilities

• Direct the programs and activities within the Quality Management Systems by providing direction, support and coaching to direct reports. Programs include processing, tracking and trending of investigations, corrective and preventive actions, inspections and release of products.
• Schedule tasks and work assignments for Product Release and Investigations Supervisor, QA Specialists, QAI Supervisor and Receiving Inspection Lead.
• Manage Product Release, Investigations, MQA and R&I personnel, and ensure quality related issues are resolved and documented in a timely and efficient manner.
• Monitor compliance and system health through KPIs and identify strategies and opportunities for quality system improvements based on a risk-based approach.
• Ownership of the TrackWise and JD Edwards software with stakeholder responsibility in software upgrade and enhancement projects. Troubleshooting of Quality Systems and implementation of systemic/procedural enhancements aimed at making such systems more robust.
• Ensure that all work activity is documented accurately in appropriate records, forms, and logs and is in compliance with requirements.
• Ensure that samples are processed and distributed to different departments in a timely manner.
• Review records for GMP compliance, accuracy and thoroughness.
• Investigate failures and deviations in manufacturing operations and initiate corrective actions. Issue investigations and perform/document investigations when required.
• Perform review and disposition of completed Investigations.
• Inform Management of problems, failures and deviations from established internal and regulatory requirements.
• Direct training activities for the department.
• Ability to effectively mentor staff for continuous development.
• Assist Management in the development, execution, and monitoring progress towards departmental goals/objectives.
• Prepare and conduct staff performance appraisals, development plans, and disciplinary activities as warranted.
• Draft and revise departmental SOPs, forms and documents. Update procedures to reflect new or changed products, processes, equipment, policies, FDA regulations, customer demands, etc. and to ensure they are current.
• Ensure timely completion of periodic (biennial) reviews of SOPs.
• Support Validation and Product Development Projects.
• Maintain and monitor QA Hold system. Ensure timely closure of TrackWise Hold Tasks.
• Initiate Hold Tasks related to QA Hold in TrackWise system. Review disposition of materials under QA Hold and assign appropriate Follow-up Tasks in TrackWise system.
• Maintain overall responsibility of ensuring QA Inspectors are trained to perform their assigned tasks.
• Analyze and resolve work problems. Interface with internal customers to address Quality and/or Batch Record issues.
• Participate in various QA activities and meetings in support of departmental functions.
• Assist Production by providing QA and R&I Inspector support
• Initiative required to generate ideas for improved process efficiency and continuous improvements within general procedural guidelines.
• Accountable for monthly/quarterly metrics and quality indicators for Product Release, Investigations and CAPA, QA Holds, QAI and R&I related activities, online inspection failures, deviations, etc.
• Discuss key metrics and performance indicators during Quality Council/Management Review.
• Establish procedures for testing drugs and related products, applying knowledge of controlled production, sampling techniques, testing procedures, and statistical analysis.
• Responsible for:
  • Sampling of all incoming components such as inactive and active raw materials, packaging components and labels.
  • Incoming quality tests on packaging materials and labeling as per specifications, SOP's and FDA requirements.
  • Delivery of samples to the appropriate laboratories and retention areas.
  • Accurate accountability of retain samples and maintain retention samples in a secured area.

Qualifications

Competencies

Education / Experience:

Minimum Bachelor degree, preferably in Sciences or related technical fields. A minimum of 10 years work experience in a pharmaceutical GMP environment, preferably in QA or related functions directly overseeing manufacturing operations.  A minimum of five (5) years supervisory experience with ASQ Certifications preferred. Demonstrated knowledge of cGMPs, FDA/DEA regulations and sampling methodologies.  PC literate with basic knowledge of MS Office application software.  Good communication (written and verbal) skills.

 

Judgment / Decision Making:

Under general direction with periodic reviews of assignments and performance measures.  Duties performed within a framework of departmental or functional protocol requiring a moderate degree of original and critical thinking and minimal supervision.  Makes routine and informed decisions to ensure product quality.

               

Work Environment:

Majority of time spent at manufacturing plants with exposure to machines with moving parts, airborne products, chemicals, muscular strain and noise.  Carelessness could result in minor injury.  May handle or work with laminate and finished product units containing a Class II Controlled Substance.

 

Physical Demands:         

Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds.  Visual acuity and manual dexterity required to proofread documents and operate computer.