QA Validation & Equipment Compliance Manager

This is what you will do

• Provide Quality oversight and formal approval for qualification and validation activities in full compliance with applicable regulatory requirements and guidelines. Lead and control the site Validation Program, covering equipment, processes, utilities, facilities, computerized systems, cleaning procedures, and laboratory instruments, ensuring that products consistently perform as intended and meet predefined quality standards.
• Ensure regulatory and GMP compliance in the management of validation and qualification processes, including oversight of manufacturing and laboratory equipment throughout their lifecycle.
• Guarantee Data Integrity compliance across all site computerized systems by ensuring proper execution and governance of Computerized System Validation (CSV) activities. The scope applies to all GMP areas of the site and extends across both Active Pharmaceutical Ingredient (API) and Finished Product manufacturing operations.

You’ll be responsible for:

Key Responsibilities

• Support the Quality Management in defining, allocating, and monitoring the budget related to departmental projects and initiatives.
• Contribute to workforce planning by assessing required FTEs and identifying necessary competencies.
• Define and maintain the internal organizational structure, including roles, responsibilities, and job assignments.
• Set and assign qualitative and performance objectives in alignment with the company’s MBO system.
• Promote team development through tailored training plans and coaching programs based on individual needs.
• Ensure that managed personnel remain aligned with corporate competency frameworks and organizational behaviors.
• Monitor adherence to company values, code of conduct, ethical standards, and applicable legal and contractual requirements.

People Management & Operational Oversight

• Manage personnel in compliance with labor laws, contractual obligations, and workplace health and safety regulations; plan and coordinate team activities and support issue resolution.
• Ensure operational efficiency and safety of departments, facilities, and equipment by planning and overseeing required maintenance activities and implementing actions to minimize health and safety risks.
• Propose necessary investments to maintain safety, compliance, and operational effectiveness.

Health, Safety & Compliance

• Ensure fulfillment of mandatory information, training, and employee instruction obligations in accordance with applicable health and safety regulations.
• Collaborate with the EHS Department in the preparation and update of the departmental Risk Assessment Document (DVR).
• Implement and oversee risk control measures, including emergency procedures and evacuation protocols in case of serious and imminent danger.
• Verify proper use and adequacy of collective protective measures and personal protective equipment (DPI), ensuring timely replacement when necessary.
• Promptly report to the employer any irregularities or situations that may pose potential health and safety risks.

You will need to have

• Bachelor’s or Master’s Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
• Minimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments, within Engineering, Production, Process Technology, QA Validation, Technical Services or Quality Assurance functions.
• Extensive experience in validation and qualification of equipment and systems within cGMP-regulated environments.
• Strong knowledge of EU and FDA regulatory requirements, with direct exposure to regulatory inspections (e.g., FDA/DEA).
• Proven background in managing validated/qualified systems.
• Strong capability to define and execute strategies to effectively manage multiple projects simultaneously.
• Solid technical problem-solving skills, with the ability to assess risks and implement balanced, compliant solutions.
• High level of initiative, accountability, and decision-making ability, with capacity to work effectively with minimal supervision.
• Excellent teamwork and interpersonal skills, with the ability to build constructive relationships across all organizational levels.

We would prefer for you to have

• Experience in Cleaning Validation is highly preferred.

Technical Competences

Validation, Qualification & Compliance Responsibilities

• Oversee the preparation and issuance of Validation Project Plans (VPP) and Validation Final Reports (VFR), actively contributing to their development.
• Supervise the preparation of Technology Transfer documentation, ensuring completeness and regulatory compliance.
• Lead validation and qualification activities by defining objectives and timelines, reviewing data, and identifying necessary corrective actions.
• Collaborate to the site equipment lifecycle management, ensuring proper execution of qualification, maintenance, and calibration plans.
• Perform QA review and approval of validation documentation throughout the equipment/instrument lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV).
• Support investigations of qualification deviations, identifying appropriate corrective actions and assessing regulatory and operational impact.
• Manage environmental validation activities and cleaning validation programs for manufacturing facilities.
• Ensure pharmaceutical transport compliance with GDP requirements through the issuance of shipping validation protocols and reports.
• Support new site projects by ensuring qualification and validation strategies meet regulatory and corporate standards.
• Contribute to the development of ongoing process verification plans and related documentation.

Data Integrity, Risk Management & Process Validation

• Ensure Data Integrity compliance through review of Computerized System Validation (CSV) documentation and support periodic review plans.
• Support process risk assessments to identify Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and define appropriate validation strategies.
• Coordinate cross-functional teams in performing risk assessments for new projects and regulatory submissions (major and minor changes), ensuring site compliance with regulatory authorities.
• Collaborate with Production to ensure compliance with GMP and production plans, supporting process validation and cleaning validation activities.

Quality System & Continuous Improvement

• Support Site Quality in the investigation of complaints and quality events; define and implement CAPA plans resulting from audits and inspections.
• Issue and maintain procedures within the area of responsibility.
• Participate in self-inspections, regulatory authority inspections, and customer audits.
• Maintain and control the Validation Change Control Program for validated/qualified systems and the Validation Management System (VMS).
• Review and approve the Validation Master Plan (VMP).
• Act as SME for process validation topics, including process changes, cleaning validation, hold times, and analytical instrumentation qualification.
• Deliver training on Validation, Qualification, and Change Management processes.
• Drive continuous improvement initiatives aimed at streamlining validation processes and reducing non-value-added activities.
• Provide leadership and guidance for validation-related CAPA activities.
• Participate in Quality Risk Management activities, contributing to FMEAs and Risk Control Plans as Validation SME.

Location

Parma