Supervisor, Quality Disposition

Curia Aalborg ApS; City of Rensselaer (NY); On-site; USD 102,000 - 128,000; Full time

Benefits offered by this job

Generous benefits

Paid training

Career advancement

Education reimbursement

401k program

Learning platform

Job summary

Curia in Rensselaer, NY seeks a Quality Disposition Supervisor to lead the batch disposition process, review batch records, and ensure compliant closure of Deviations, CAPAs, Change Controls, and investigations. The role supervises the disposition team and interfaces with cross-functional groups to meet supply commitments.

The ideal candidate has a minimum of six years in GMP and at least four years in quality disposition reviews in a supervisory role, with strong data integrity and regulatory

Qualifications

• Bachelor’s degree in science or related study.
• Minimum of six (6) years of GMP experience in an FDA regulated pharmaceutical environment including minimum of four (4) years of experience in a Quality disposition reviews in a supervisory role.

Responsibilities

• Acts as the point of contact for product disposition.
• Review disposition packages and drive quality decisions based on data and regulatory requirements.
• Ensure batch records are reviewed before disposition within established timelines.
• Close Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-New York client products.
• Interface with cross-functional departments to resolve batch record comments compliantly.
• Serve as SME for all quality issues related to batch release.
• Develop Quality disposition and batch record reviewer qualification program.
• Contribute to training feedback loops from batch records reviews to drive continuous improvements.

Skills

GMP experience

Batch disposition

Data integrity

Leadership

Cross-functional collaboration

Quality decision making

Regulatory awareness

Coaching and mentorship

Education

Bachelor’s degree in science

Job description

Quality Disposition Supervisor in Rensselaer, NY

Our Rensselaer site is undergoing a crucial quality transformation. This is a rare opportunity to join a highly visible project, re-engineer quality systems from the ground up, and gain unmatched regulatory exposure.

The Quality Disposition Supervisor will be responsible for the disposition of intermediates, API’s and incoming materials. This role will require leading the team responsible for batch dispositions and will also lead the site disposition reviews to meet supply commitments. Acts as a primary gate keeper for the disposition process at the site, ensuring batch record reviews are completed in a compliant manner, all deviations impacting the disposition are closed, QC data is reviewed per the procedures, all open change controls and CAPAs tied to the batch disposition are assessed and impact is documented. Ensures the breakdown/demand maintenance workorders impacting the batch are reviewed prior to the disposition and Quality impact assessment is documented.

Build your future at Curia, where our work has the power to save lives.

What We Offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401k program
• Learning platform
• And more!

Essential Duties and Responsibilities

• Acts as the point of contact for product disposition
• Be able to objectively and comprehensively review disposition packages and drive Quality decisions related to product disposition based on data, strong technical & scientific rationale, data integrity requirements, compliant to regulatory and site procedural requirements
• Responsible for ensuring batch records have been thoroughly reviewed before product disposition to the customer within established timelines
• Responsible for closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-New York client products
• Interfaces with the cross functional departments to resolve any comments from the batch record reviews in a compliant manner
• Key point of contact for addressing product disposition related questions in customer audits and regulatory inspections
• Will act as subject matter expert for all quality issues related to batch release
• Will be responsible to develop Quality disposition and batch record reviewer qualification program
• Play a key role in creating training feedback loop from batch records reviews with manufacturing and other cross functional teams to drive continuous improvements

Education and Experience

• Bachelor’s degree in science or related study
• Minimum of six (6) years of GMP experience in an FDA regulated pharmaceutical environment including minimum of four (4) years of experience in a Quality disposition reviews in a supervisory role

Supervisory Responsibilities

• This role has supervisory responsibilities, involves mentoring, guiding, and advising.

Other Skills and Abilities

• Leads with integrity and respect
• Provides guidance, coaching, and mentorship to team members, sitewide
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Ability to work promptly and under pressure to meet customer and business deadlines associated with batch record lot release

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Pay Range: $102,000-$128,000/yr

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.