Senior Manager, QA Validation

Tonix Pharmaceutical • Chatham, NJ

47d • $100,000 - $170,000

About The Position

The Senior Manager, Validation, situated within the Quality Assurance department, will provide quality support on validation activities for internal and external (i.e., contract organizations) GxP computer systems and data integrity processes. This position will be responsible for ensuring equipment and systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies. They will ensure consistent application and maintenance of Validation procedures This position will collaborate cross-functionally for on-going activities in support of validation activities occurring both internally and at Tonix contracted organizations including support of risk assessments, deviations, CAPAs, and change controls. The Senior Manager, Validation, will lead, direct, and advise continuous improvement of the department's area of control, and assist in any other area as needed or directed by management.

Requirements

• Proficiency with Quality system applications (e.g., eDMS, QMS)
• Dedicated team player who is able to withstand the high demands of a fast-paced environment.
• Results driven, problem solver, and collaborator Excellent written and verbal communication skills
• Excellent planning and time management skills and the ability to handle several tasks simultaneously.
• Comfortable working independently with minimal supervision
• Ability for travel up to 20% of the time
• Must be able to provide clear direction while motivating teams.
• Must lead by example through strong work ethics and high standards.
• Bachelor of Science degree in Engineering or related field.
• 10+ years of experience in the biotech industry and 2+ years of management experience.
• Demonstrated knowledge of cGMPs for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASME BPE, PIC/S ISPE Baseline Guides ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices.
• Demonstrated experience in IT System/Software Development Life Cycle (SDLC), change controls, validation needs, and activities.
• Demonstrated expertise in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and knowledge of applicable Codes of Federal Regulations as they apply to computerized systems, e.g., GxP, validation, 21 CFR Part 11, CSA, etc.
• Strong understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory guidance is critical.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles as they relate to qualification and validation issues. Experience presenting these outcomes to senior management.

Nice To Haves

• Experience with personnel management and development.
• Strong project management skills.
• Working knowledge in Facility, Utility & Equipment Qualification, Process Validation, and Quality System Management.
• ASQ certification (e.g., certified quality engineer, quality auditor, manager of quality / organizational excellence.

Responsibilities

• Ensure the validated status of GxP computer systems used to support GxP activities, is established in accordance with internal procedures, regulatory requirements and industry guidance / standards.
• Define computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices.
• Responsible for maintaining the CQV and CSV programs in a state of compliance.
• Establish and provide quality and technical input on the development of policies, procedures, standards and templates
• Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports.
• Develop validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements.
• Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 requirements are met. Implement and ensure effective data integrity controls and practices.
• Evaluate proposed changes to validated computer systems and recommend the level of validation activities required.
• Manage and perform all Quality System functions for the department including impact assessments, deviations, CAPAs, change controls, SOP revisions, and audit responses.
• Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities.
• Must comply with all applicable rules and regulations of Emergent and Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations. Will maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation.
• Define and communicate metrics used to track performance relevant to the operations qualification programs' activities / responsibilities and ensure commitment to key stakeholders and company goals are met.
• Set and manage clear operational priorities.

Benefits

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary stock options
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Career Development and Training

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Number of Employees: 51-100 employees