Quality SME, Production & Process Controls

What you'll be doing

• Serve as the division Quality Compliance technical SME for production and process controls, including statistical sampling, in-process control checks, manufacturing process flows, and batch record compliance across ITP sites.
• Provide strategic and technical Quality Compliance guidance on production and process controls for sterile preparations, with a focus on manufacturing process controls and their compliance adequacy.
• Provide specialist guidance and independent compliance assessment of visual inspection programs, including inspection methods, qualification, defect classification, acceptance criteria, sampling strategies, investigations, and inspection performance trends.
• Provide specialist Quality Compliance guidance on particulate matter prevention and control, including assessment of particulate sources, monitoring and trending, investigation adequacy, and the effectiveness of site-owned corrective and preventive actions.
• Provide specialist Quality Compliance guidance on container closure integrity testing (CCIT), including review of testing strategies, method suitability and validation, lifecycle controls, investigations, and remediation adequacy, in partnership with relevant site functions and the Sterility Assurance SME.
• Support all sites in sustaining an Always Inspection Ready state through risk-based assessments, readiness reviews, mock inspections, coaching, and timely closure of identified gaps.
• Provide direct technical support during health authority inspections, including real-time assessment of production and process control questions, evidence review, response development, and follow-up commitments.
• Lead or support technical compliance assessments and remediation oversight associated with inspection observations, regulatory commitments, significant quality signals, and systemic production or process control weaknesses; challenge whether site-owned actions are risk-based, sustainable, and verified for effectiveness.
• Independently assess end-to-end manufacturing processes for compliance with approved procedures, validated process requirements, product specifications, and regulatory expectations, and recommend actions to address identified gaps.
• Perform and lead risk-based assessments of manufacturing operations, process control systems, production practices, manufacturing documentation, and operational execution.
• Review and challenge manufacturing-related deviations, investigations, process excursions, batch failures, human error events, repeat deviations, and product impact assessments.
• Evaluate process control strategies, in-process monitoring programs, alarm management practices, and manufacturing controls to ensure consistent product quality and process robustness.
• Provide technical compliance guidance on site-owned remediation plans addressing manufacturing compliance gaps, process weaknesses, recurring deviations, and inspection observations; review their adequacy and effectiveness.
• Assess procedural adherence, manufacturing discipline, shift execution, line clearance practices, batch documentation practices, and operational GMP behaviors; identify compliance gaps and recommend improvements to accountable site functions.
• Provide independent compliance review and technical guidance on proposed manufacturing process changes and standardization, using quality risk management and process performance monitoring to assess whether controls remain adequate.
• Partner with site leadership to improve investigation quality, root cause analysis, CAPA effectiveness, and operational ownership of compliance issues.
• Conduct site assessments, manufacturing system reviews, gap analyses, and mock inspections to identify vulnerabilities and opportunities for improvement.
• Monitor manufacturing compliance performance, recurring trends, process capability indicators, and operational risk signals, escalating significant concerns as necessary.
• Coach and mentor manufacturing, quality, and technical personnel on production controls, process discipline, GMP expectations, and regulatory requirements.
• Interpret current regulatory expectations and industry best practices related to pharmaceutical manufacturing operations and process control systems, and advise site functions on compliant implementation.

What you'll bring

• Bachelor's degree in engineering, Pharmacy, Chemistry, Life Sciences, Manufacturing, Industrial Engineering, or related technical discipline required. Advanced degree preferred.
• Minimum 15 years of experience in pharmaceutical quality, compliance, manufacturing, process engineering, technical services, or related technical functions, including substantial experience assessing production and process controls from a quality and compliance perspective.
• Experience in sterile manufacturing, injectable products, IV solutions, aseptic processing, biologics, or combination products.
• Deep technical knowledge of pharmaceutical production and process controls, batch execution, and production quality systems, with the ability to apply this expertise in independent Quality Compliance assessment and oversight.
• Demonstrated specialist expertise in production and process controls for sterile preparations, visual inspection, particulate matter prevention and control, and container closure integrity testing (CCIT), with the ability to provide strategic and practical technical guidance, independently assess compliance gaps, and challenge the adequacy of site-owned controls and remediation.
• Strong understanding of current global regulatory expectations applicable to pharmaceutical manufacturing, including FDA, EMA, MHRA, Health Canada, ANVISA, INVIMA, TGA, and other health authorities.
• Demonstrated experience supporting health authority inspections, regulatory responses, and remediation activities involving manufacturing and production control systems.
• Strong knowledge of pharmaceutical manufacturing processes, process control strategies, batch manufacturing practices, manufacturing documentation systems, electronic batch records and manufacturing systems, deviations and investigations, CAPA systems, process validation lifecycle concepts, change control systems, quality risk management, data integrity requirements, and Continued Process Verification (CPV).
• Strong understanding of manufacturing execution systems, operational controls, and product lifecycle management within GMP-regulated environments.
• Ability to evaluate complex manufacturing issues, identify systemic vulnerabilities, and provide practical, risk-based recommendations.
• Strong root cause analysis, investigation, CAPA development, and effectiveness verification skills.
• Effective communication, facilitation, coaching, and influencing skills with the ability to work directly with plant leadership and cross-functional manufacturing teams.
• Ability to maintain a strong on-site presence and travel regularly among supported manufacturing locations.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.