Data Integrity Compliance Officer

Job Description

Data Integrity Compliance Officer 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.

We proudly 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 with matching contributions
• Learning platform
• And more!
  
  
  

Position overview

The Site Data Integrity Compliance Officer 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 Officer will report into 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.

Essential Job Duties

• 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 assure 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
  
  
  

Education, Experience, Certification And Licensures Required

• 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
  
  
  

Preferred

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

Knowledge, Skills And Abilities

• 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
  
  
  

Pay Range: $152,000 - $189,000

Education, experience, location and tenure may be considered along with internal equity when job offers are extended. Supervisory responsibilities

This position does not have supervisory responsibilities.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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.