Associate Director, Inspection Readiness and CAPA
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Responsible and accountable for managing, directing and coordinating Inspection Readiness and CAPA Management activities within DM Operations. Contributes to the strategy of Clinical Data Management group and implementation of enhanced quality systems and standards within Global Development with partner QA/GCP Compliance functions. Participate, as needed, in initiatives within Global Development. Lead the Inspection Readiness and CAPA Management group to provide full support of HA inspections with enhanced regulatory awareness, provide guidance to data managers included in an inspection, be the primary point person for all inspections involving the Data Management function, and ensure CAPAs are properly drafted and closed.
- Establish and maintain a partnership relationship with GCP Compliance roles and customer-orientated approach within the DM Inspection Readiness and CAPA Management group
- Drives the vision for inspection readiness through proactive internal reviews, providing teams with support to resolve obstacles to process adherence and well documented training delivered by SMEs and other qualified instructors.
- Responsible for proposing/defining internal DM quality-related metrics as well as ongoing collection and quarterly (?) reporting of DM quality-related metrics including inspection-related metrics and governance of HA responses and CAPA fulfillment
- Support the improvement in quality within Data Management by proactively identifying and addressing areas of concerns from Health Authority inspection findings to avoid downstream issues. Assist the Director, Data Management Operations to drive a quality, compliance and quality process improvement mindset within Data Management and neighboring functions.
- Collaborates closely with Global Development functions, to ensure that CAPA fulfilment activities are defined, measured, managed and that learnings are leveraged to improve efficiency and quality of clinical trial collection, analysis, reporting and submission across the portfolio of studies.
- Coordinate with GCP Compliance and neighboring functions to assess the portfolio for near, medium, and longer term likelihood of future DM-related inspection targets (i.e. identify subset studies pivotal to approvals or of special interest in key countries). Based on this info, use a risk-based approach to selectively perform internal quality reviews as well as prioritization of efforts to remediate any historical problems.
- Represents Data Management in cross functional process discussion to ensure core needs of the department are met with regard to CAPAs and other process improvement initiates.
- Ensure that significant DM-related process changes/improvements are rolled out with appropriate detailed implementation plans that take into account the various statuses and outsourcing partners of ongoing studies across the portfolio. Ensure that appropriate documentation is produced/maintained exempted studies for new SOPs.
- Provides input to and undertake the implementation and maintenance of global working practices and standards. Contributes to development of appropriate job aids to facilitate adherence to process and documentation requirements.
- Contributes to the development of the Clinical Data Management organization through his/her leadership role on the management team.
- May lead and support clinical & non-clinical special projects.
- Ensures adequate resources are in place to support all company inspections
- Defines and implements a minimally intrusive internal review approach to identify potential quality problems (i.e. training gap, misinterpretation of a process detail, documentation burdens/weaknesses, etc.) in ongoing studies and facilitate proactive remediation before minor issues become significant quality risks.
- Establish criteria to assess the effectiveness of corrective actions, and periodically assess the effectiveness of training and job aids for new processes or changes to documentation requirements.
- Accountable to ensure that learnings from audits, inspections, and internal reviews, are strategically translated into positively framed actionable feedback to drive improvement.
- Lead (or coordinate with others as appropriate) consequent updates to processes, standards, training and ensure that implementation strategies take into account the broad range of statuses and prior processes used across the whole portfolio of studies.
- Serves as an internal departmental quality/compliance expert to provide consultative support to study teams with quality/compliance-related questions/concerns and/or those requiring assistance to resolve an historical/ongoing problem.
- Adheres to procedures surrounding retention of data, records, and information for clinical studies
- May provide Subject Matter Expert Support for select topics assigned
Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data management operations or data management experience and 10 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.
- Self directed and comfortable working in cross-functional teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required.
- Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required.
- Ideally 10 or more years’ experience in data management, with 5 or more years in Operations knowledge.
- Strong understanding of regulation and guidance for drug studies including: ICH guidelines on GCP (E6, E2A and E8) and applicable regulatory requirements, specifically 21CFR sub-parts 50, 54, 56, 312 and 314 as well as the European Directives on GCP (2001/20/EC and 2005/28/EC).
- Proficiency with Medidata Rave a plus.
- Additionally, Microsoft Office applications.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.