Regulatory Specialist

Summary

2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Must have GMP, Quality, and in-depth risk management knowledge.

• Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.

• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.

• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.

• Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.

• Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.

• Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.

• Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.

• Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.

• Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.

• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

• Consults management for advice on complex issues.

• Work is self-directed.

• Is recognized Subject Matter Expert within the group.

• Able to prepare written communications and communicate problems to management with clarity and accuracy.

• Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.

• Understands fundamental scientific problems.

• Able to write and review reports with clarity and brevity.

• Able to produce data reports with precision.

3. DUTIES AND RESPONSIBILITIES

• Supports all activities for the QA Engineering group.

• Support cross functional departments on risk identification, root cause analysis and investigative measures and support evaluation and implementation of a plan to mitigate process and/or product risks

• Contribute to the writing, coordination, review, approval and maintenance of the Warren Risk Management Standard Operating Procedures (SOPs) and associated documentation.

• Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.

• Develops and Maintains Quality Metrics to monitor compliance

• Evaluate and report key performance metrics, analyze data and lead improvement initiatives.

• Support risk owners in planning, execution and completion of risk assessments by providing direction, and guidance to cross functional teams.

• Occasionally, facilitate complex or highly cross-functional risk assessments

• Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with Warren Quality System.

• Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.

• Drive continuous improvement for effective risk management and to address recurring issues identified throughout Warren.

• Track and verify appropriate corrective actions have been implemented, documented and align with source event.

• Maintain Warren Quality Risk Catalog, Risk Register Registry and track the status of risk mitigation actions through to completion.

• Assist the risk owner to schedule and facilitate Warren risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.

• Conduct risk reviews and escalate findings, as appropriate, to Manager and Warren Leadership with resolution and recommendations.

• Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.

• Work independently and perform with a high degree of accuracy.

• Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.

• Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.

• Provide subject-matter expertise and consultation to risk assessment teams at the site. Develop and deliver training on QRM concepts, methods and regulatory expectations.

• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues

• Act as primary link to other CTDO sites to ensure Quality systems are properly implemented and consistent

• Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.

• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.

• Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.

• Review media simulation activities to ensure successful execution and documentation.

• Ensure site is compliant with global and regulatory data governance and data integrity requirements.

• Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.

• Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.

• Ensure procedures are adequate to review and confirm appropriateness of laboratory raw data.

• Review/approval of technology transfer related deviations/discrepancies.

• Ensure the site stability program meets global and regulatory requirements.

• Ensure process and method transfers, method qualifications/verifications, and analyst trainings meet company and regulatory requirements.

4. EDUCATION AND EXPERIENCE (As Applicable)

• B.S. degree required.

• Minimum of seven years of experience in the pharmaceutical or related industry.

• Experience in CAR T or Biologics preferred.

• Professional certification in Quality Risk Management preferred.

• Equivalent combination of education and experience acceptable.