Manager, Quality Compliance

Curia • City of Rensselaer, NY

13h

About The Position

Manager, Quality Compliance in Rensselaer, NY

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

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

The Manager of Quality Compliance plays a critical leadership role within the Curia Rensselaer team, overseeing key elements of the Quality System and Data Integrity to ensure sustained regulatory compliance and continuous improvement. The Quality Compliance Manager is responsible for providing independent hands-on compliance oversight for day-to-day cGMP operations, GMP activities and adherence to data integrity policies. The Compliance Manager will report to the Business Unit Quality Head and is responsible for reporting non-compliance to GMP and Data Integrity policies.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

• Bachelor's degree in Science, Chemistry, Biology or related field
• Minimum 10+ years’ experience in the pharmaceutical products/medical devices industry, including QA and compliance, and Quality Systems
• Must have experience in data integrity and compliance remediation efforts at a site level
• Understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, and quality assurance requirements for intermediate and Drug Substance manufacturing
• Knowledge of CGMP industry guidelines and requirements
• Strong knowledge of plant quality systems, plant data systems, and deviations
• Strong Leadership skills
• Strong attention to detail
• Ability to read, understand, interpret, and apply technical writing and instructions
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Knowledge of manufacturing, spreadsheet and word processing software
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience working with third-party contract manufacturing in the Pharmaceutical industry
• Minimum 8 years’ managerial experience in Quality Assurance

Responsibilities

• Provide Quality leadership to ensure manufactured products maintain compliance with regulatory expectations and submissions.
• Serve as resident QA GMP and data integrity expert in support of Good Documentation Practices and will be responsible to independently assess the health of the Quality System supporting manufacturing and laboratories.
• Perform random audits of Change Control System process to ensure that all changes to equipment, products and processes are appropriately documented, executed, tracked and approved.
• Perform data integrity assessments on systems & processes and provide periodic updates to quality management.
• Ensure CAPAs for any internal audit or customer audit findings are comprehensive and holistic.
• Provide guidance on internal quality issues, customer concerns and regulatory issues.
• Review audit observations and final audit reports from internal/external audits and inspections and ensure a holistic CAPA response is submitted with appropriate effectiveness checks.
• Review and verify corrective/preventive actions and ensure they are implemented in a timely manner.
• Provide periodic training on Data integrity and cGMPs to staff in GMP operations.
• Provide status updates to corporate quality on data integrity and site quality improvement plans.
• Perform periodic audit of production batch records, and/or QC data including electronic data, to ensure adherence to Corporate and Site policies, SOPs, and cGMP requirements.
• Oversight of operations and QC through the site walkthrough program and verify appropriate Quality System processes are used to address the findings.
• Initiate Notification to Management for all DI related issues
• Develop and monitor metrics for independent audits performed and site walkthrough programs and ensure the site leadership drives continuous improvements
• Lead investigations into suspected data integrity violations.
• Ensure deviation reports are initiated into the system and impact assessments completed in stipulated time frames including extensions for past due records. Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction in collaboration with Production.
• Verify site internal audit program is effective and compliant
• Support the site in inspection readiness through active coaching and mentoring during the walkthroughs and audits
• Interact and participate in Regulatory Inspections, as needed.
• Drive, monitor and ensure delivery of the Site DI Plan, including DI communication and engagement plan, and periodically report status / progress to Corporate leadership and support Notification to Management.
• Continuously improve data integrity knowledge base and understanding: Identify training needs and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training.
• Part of Curia Compliance Bench Marking Forum to monitor emerging inspection/regulatory trends
• Drive sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks etc.
• Site champion for driving compliance and quality culture

Benefits

• 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 with matching contributions
• Learning platform
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees