Director, Manufacturing Compliance (Fill/Finish)

About the role

The Director of Manufacturing Compliance will be accountable for leading and developing the Fill/Finish Manufacturing compliance organization, with direct oversight of Change Control, Manufacturing Investigations and CAPA management functions. This role serves as the primary compliance interface between Fill/Finish Manufacturing and IOPS-level quality, regulatory, and governance bodies representing the manufacturing function in all compliance escalations, health authority interactions, and cross-functional governance forums. The Director drives a culture of continuous compliance improvement, monitors team KPIs, and ensures the sustained inspection readiness of fill/finish operations. In a supporting and partnering capacity, this role maintains close collaboration with Fill/Finish Operations leadership to align compliance priorities with production objectives and patient supply commitments. This is a leadership role requiring deep GMP expertise, organizational effectiveness, and the ability to lead multi-tiered compliance teams.

Schedule & Location

East Greenbush, NY. Monday-Friday, 8am-4:30pm.

Responsibilities

• Provides leadership, vision, and management to the Manufacturing Compliance & Services team, with direct oversight of Change Control and Manufacturing Investigations sub-teams.
• Directly oversees the Fill/Finish Change Control program, ensuring timely, risk-based evaluation of all manufacturing changes across equipment, processes, materials, facilities, and systems.
• Directly oversees the Manufacturing Investigations and CAPA program, including deviation management, root cause analysis, effectiveness checks, and timely closure of GMP events originating from fill/finish operations.
• Monitors, manages, and reports team KPIs across all compliance sub-functions; presents performance metrics to site and IOPS leadership on a recurring cadence.
• Conducts trend analysis across investigations and deviations to identify recurring failure modes and systemic improvement opportunities.
• Represents Fill/Finish Manufacturing at compliance meetings, governance forums, and health authority interactions; leads escalation response for manufacturing compliance issues.
• Partners with Fill/Finish Operations leadership in a supporting capacity to provide compliance guidance on process challenges, validation activities, and new technology introductions.
• Leads annual merit performance reviews, develops long-term staffing plans, and collaborates with Directors on annual budget development.
• Rapidly communicates compliance risks to department Directors and Senior Leadership; resolves issues to mitigate patient supply disruptions.
• Works effectively across departments including Quality Assurance, Facilities, Engineering, MSAT, Regulatory Affairs, Quality Control, IT, and Supply Chain.
• Writes, reviews, and/or approves SOPs, specifications, regulatory filings, and other controlled documents; executes QMS assignments (CAPA, Deviation, Investigation, Change Control).
• Maintains site inspection readiness and represents the manufacturing compliance function during regulatory and client audits; participates in cGMP audits of all production areas.

Qualifications

• BS/BA in any of the physical or biological sciences, or chemical engineering and 12+ years of industry experience or equivalent combination of education and experience.
• Demonstrated compliance leadership with experience leading multi-tiered QMS functions (Change Control, Investigations, CAPA) in an aseptic biologics GMP manufacturing environment; multiproduct facility experience preferred.
• Deep working knowledge of GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q10) and experience interacting with multiple health authorities (e.g., FDA, EMA, PMDA).
• Must have a sustained mindset for inspection readiness; proven ability to develop and monitor compliance KPIs and translate data trends into actionable improvement strategies.
• Proven ability to lead cross-functional and direct-report teams; excellent at collaborating across Quality Assurance, Facilities, Supply Chain, Regulatory Affairs, and Engineering to remove barriers and build alignment.
• Effective communicator across all organizational levels, from frontline manufacturing teams to IOPS Senior Leadership and health authority representatives.
• Excellent at developing staff, teams, and future compliance leaders; leads by example with a passion for continuous improvement and critical thinking.
• Strategic thinker who can solve complex compliance challenges, quickly adapt to emerging situations, and interpret data to drive decisions and promote organizational health.

Pay

$172,200.00 - $286,900.00 annually.