Associate Director Data Management - Inspection Readiness & CAPA Management

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 14, 2022

Job Description:

Responsible and accountable for handling, 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.Responsibilities

• 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 mentality within Data Management and neighboring functions.
• Collaborates closely with Global Development functions, to ensure that CAPA fulfillment activities are defined, measured, handled and that findings are used 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. Gives to development of appropriate job aids to facilitate adherence to process and documentation requirements.
• Gives to the development of the Clinical Data Management organization through their 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 findings from audits, inspections, and internal reviews, are strategically translated into positively framed useful feedback to drive improvement.
• Lead (or partner 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 authority to provide consultative support to study teams with quality/compliance-related questions/concerns and/or those requiring assistance to resolve an historical/ongoing problem.To be considered
  • 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 management skills. Strong written and oral communication skills required.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Associate Director Data Management - Inspection Readiness & CAPA Management, Executive , Basking Ridge, New Jersey