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Associate Director, QA Operations

Associate Director, QA Operations

TANVEX BIOPHARMA USA INCSan Diego, CA, US
3 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Description : SUMMARY

The Associate Director, QA Microbiology & Validation will be responsible for managing and leading the Validation program for Tanvex's manufacturing and testing facility. will establish validation and re-validation policies, programs and procedures for processes, equipment, software, and systems that comply with Good Manufacturing Practices and oversee the execution of new and routine validation activities. is responsible for overseeing the environmental monitoring program and testing samples for microbials throughout the manufacturing process.

JOB RESPONSIBILITIES

Essential

Validation

  • Maintain all necessary Validation Plans, including strategies, work schedule / timelines, and resource planning / requirements.
  • Develop and maintain / update Validation SOPs to ensure consistent application of the requirements and strategies.
  • Recommend and implement improvements to Validation and associated quality systems in order to make them robust, compliant, and defendable.
  • Plan, coordinate, and direct site validation activities of new, modified, and existing facilities. Manage resources to ensure timelines, budget, and milestones are met. Ensure all personnel (internal and contractors) utilized to perform validation activities have the appropriate resources, skill set and required training.
  • Provide effective leadership including individual goal setting / performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
  • Oversee validation efforts performed by contract service providers.
  • Support development of other lifecycle documentation including user / system requirements, risk assessment, design qualification, review and approve site procedures.
  • Ensure that validation data and records are properly managed and maintained.
  • Work closely with Quality, Process Development, Facilities, and Production to investigate and resolve deviations through determining root cause, product impact, and appropriate corrective and preventive actions related to equipment or validated process parameters.
  • Provide responses to audit observations and manage audit related CAPA commitments.
  • Support validation review of investigations and change management as well as facility inspections, audits (both performed by internal groups and by regulatory agencies), regulatory submissions and annual product reviews.

Microbiology

Manage sampling of non-viable air, viable air, and viable surface samples for manufacturing clean rooms, incubations of samples and reading / interpreting / reporting of results.

  • Oversee gowning qualifications for clean room personnel.
  • Manage sampling and testing of RODI and WFI water systems. .
  • GMP documentation of laboratory testing using forms and logbooks and summarizing of test results.
  • Oversee routine microbiological testing such as endotoxin and bioburden testing for GMP samples, including product and clean utilities.
  • Lead investigations into testing failures, identification of root causes, and implementation of corrective actions.
  • Technical expertise with environmental monitoring equipment.
  • Coordinate with the Operation groups to ensure the facilities and.utilities are operational.
  • Assist in improving QC systems as assigned by Manager, including revising QC system, Standard Operating Procedures (SOPs) or analytical test method.
  • Compile data and complete documentation of test procedures in accordance with current Good Manufacturing Practices (cGMP).
  • Review testing data of other QC Associates and Scientists, as applicable to ensure cGMP compliance.
  • Review documents and author documentation such as SOPs, Test Methods, Validation Protocols and Validation Reports.
  • Lead and guide QC Associates to ensure compliance in all the testing activities.
  • Provide effective leadership including :

    • o individual goal setting / performance reviews.

    o motivate employees, provide coaching and feedback for individual career growth and development.

    o recognize and appreciate employee contributions.

    o mitigate conflict and communication problems.

    o plan and facilitate team activities.

    o recruit / hire personnel.

    o provide training and emphasize best practices.

    o recommend and present disciplinary actions to subordinates when required.

  • Supplemental Responsibilities
  • Assist with writing, reviewing and executing FATs, SATs, IOQs.

    • JOB REQUIREMENTS

    Education and Experience

  • BS in Engineering, Chemistry, Biochemistry, Microbiology, Pharmaceutics, Chemical Engineering, Biology or related life sciences or engineering field. Advanced degree (MS or MBA) is desirable.
  • 10 years’ experience in Quality Control within GMP biopharmaceutical or biotechnology industry, or equivalent combination of education and experience.
  • Experience with regulatory compliance inspections is required.
  • Recent Quality Control / Analytical / Method Validation experience with Biologics strongly preferred.
  • At least 5 years of direct management experience.

    • Knowledge, skills and abilities

  • Expertise leading Process Validation, Equipment Validation, Computer System Validation, Analytical Methods Validation, CAPA Systems and Manufacturing Support.
  • Desirable GMP validation experience includes Process Equipment, Utilities, Laboratory, Automation, Computer Systems (LIMS, Delta V, Automation Systems, BMS and MES), Sterilization, and Automated Drug Product Filling Systems.
  • Experience using risk-based approach (FMEA, PHA, etc.).
  • Excellent technical writing and verbal communication skills.
  • Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
  • Demonstrated ability to manage multiple activities while maintaining a high level of organization.
  • Demonstrates initiative; ability to take on additional responsibilities and respond to situations as they arise with little or no supervision.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals.
  • Extensive working knowledge of GMP regulations and experience with regulatory compliance inspections.
  • Strong knowledge of 21CFR210, and 21CFR211 as it relates to testing.
  • Cleanroom gowning in Class 10,000 and 100,000 environments.
  • Gowning qualifications for Class 100 environments.
  • Technical expertise with environmental monitoring equipment.
  • Ability to work in a fast-paced, start-up environment.
  • Strong attention to detail.
  • Capable of being organized and managing multiple projects and responsibilities simultaneously.
  • Ability to manage multiple projects and priorities, good organizational and problem solving skills.
  • Knowledge of Microsoft Office suite (Excel, Word, PowerPoint).

    • Requirements :