R&D Quality Risk Manager

Integrated Resources, Inc ( IRI ); Princeton (NJ); Hybrid; USD 120,000 - 130,000; Full time

Job summary

Integrated Resources, Inc (IRI) in Princeton, NJ is seeking a Manager of R&D Quality Risk Management III to oversee quality risk activities for clinical trials in a GCP-regulated environment. Role involves collaboration with CSPs, CROs and internal R&D teams to implement QRM improvements.

The candidate will identify emerging risks, develop metrics, coach junior staff, and stay current with ICH guidelines and regulatory expectations, while supporting drug development programs.

Qualifications

• Minimum 6 years in an R&D or pharmaceutical setting within a GCP environment.
• Experience with R&D QRM or QA systems and Health Authority regulations.
• Familiarity with CTMS, eTMF, eCRFs and QA workflow systems.
• Excellent verbal and written communication; able to work cross-functionally.

Responsibilities

• Contribute to effective quality control and risk management of R&D procedures and processes.
• Improve clinical trial processes and SOPs across Clinical Operations, PV and Data Management.
• Create and track semi-automated metrics and KPIs to reinforce process adherence.
• Lead trial risk management strategies for development teams, CROs, CSPs, and regulators.

Skills

GCP knowledge

Quality risk management

Regulatory knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor's or Master's in relevant field

Tools

CTMS

eTMF

eCRFs

Excel

Job description

Title: Manager, R&D Quality Risk Management III

Location: Princeton, NJ - Hybrid Role 3days onsite

Pay: $58.65/hour on W2.

Position Summary:

• Responsible for managing assigned Research and Development (R&D) Quality Risk Management activities at Client, including assessment and quality control of Client clinical trials' execution in a Good Clinical Practices (GCP) regulated environment.
• Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP). Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted.
• Will be required to identify emerging issues and compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to (or lead efforts to) their implementation. Potential to coach and support junior associates in R&D Quality Risk Management (R&D QRM) department, where needed.

Primary Responsibilities:

• Contribute to effective quality control and risk management of Client R&D procedures and processes.
• Ensure the continuous improvement of clinical trial processes and associated SOPs within Clinical Operations, trial monitoring, Data Management and Pharmacovigilance (PV).
• Create new appropriate process and/or compliance indicators (semi-automated metrics and manual spot-checks) in order to reinforce adherence to internal processes and procedures and to identify areas for improvement. Calculate, track and report such indicators on a continual basis. Work in close collaboration with colleagues in R&D Quality Management, Client operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA).
• Provide input on quality and compliance concerns and lead implementation of trial risk management strategies in support of clinical development teams, CROs, contractors and consultants. Maintain and where needed update aspects of the R&D QRM framework, e.g. internal procedures, processes training modules and tools. Lead the organization through QRM related changes, e.g. updates from ICH, regulatory guidances and business best practices.
• Product: May provide guidance to subordinates and/or manage department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems.
• Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals.
• Works on issues of diverse Product which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements:

• While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.
• Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.

Experience:

• An equivalent combination of relevant education and applicable job experience may be considered. Minimum of 6 years R&D focused pharmaceutical/Health Care experience in a GCP regulated environment including some experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority regulations. Experience in a matrix team environment and involvement and contribution to continuous improvement projects. Must possess:
• Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management. Strong knowledge of GCP, including affinity with quality management and performance metrics and experience with Root Cause Analysis and CAPA development.
• Experience with multiple IT programs and systems, including but not limited to Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office (including above average Excel skills), quality workflow systems. Knowledge of Good Laboratory Practices, PV, FDA and/or EMA/MHRA regulations.
• Excellent communication skills, both verbal and written. Able to work independently as well as in cross-functional teams.
• Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.
• Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
• Ability to establish and maintain frequent internal and external relationships with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, regulatory agencies, CROs, clinical investigators, etc. Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues and the pro-active management of GCP and PV quality risks – under supervision if needed. Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions.
• Skilled at working effectively with business partners and management, and appropriately signal and escalated matters of significance to the organization.
• Ability to travel up to 10% of the time. Desired:
• Experience with organizational change management, especially as it relates to embracing and promoting a culture of quality.
• Experience with multi-sized organizations from start-up to large employers. Experience with QA audits and Health Authority Inspections by FDA, EMA, MHRA, and PMDA. Experience with Computer System Life Cycle management and principles.
• Familiarity with Central Nervous System (CNS) therapeutic area is a big plus.

Education:

• Bachelor’s or Master's degree in a relevant field (e.g. biology, nursing, neuroscience, psychology, biochemistry, clinical pharmacology, or related).