Quality Risk Management Manager

Pride Health is partnering with a global biopharmaceutical organization to identify a R&D Quality Risk Management Manager, for an opportunity near Princeton, NJ.
 
Important Details:

• 12-month contract with the possibility to extend
• Princeton, NJ- fully onsite
• Monday-Friday (40 hours/week)
• Pay range: $50-60/HR, depending on experience

Responsibilities:

• Partner closely with Clinical Operations, Data Management, Pharmacovigilance, Regulatory Affairs, CROs, and other R&D stakeholders to identify compliance risks, develop performance metrics, conduct root cause analysis, and drive continuous process improvement.
• Lead and support GCP quality risk management, quality control, and compliance activities across clinical development.
• Identify emerging risks, develop quality/compliance metrics, and implement process improvements and risk mitigation strategies.
• Support CAPA, Root Cause Analysis, SOPs, audits, and regulatory compliance initiatives.
• Collaborate with internal R&D teams, CROs, and Contract Service Providers on clinical trial quality and risk management.
• Maintain and enhance the R&D QRM framework, including procedures, training, tools, and processes.
• Support areas such as Pharmacovigilance, GLP, and Computer System Validation as needed.
• Provide guidance and coaching to junior team members.

Minimum candidate qualifications and experience:

• Bachelor's or Master's degree in a relevant field (e.g., biology, nursing, neuroscience, psychology, biochemistry, clinical pharmacology, or related)
• 6 years of pharmaceutical/healthcare R&D experience in a GCP-regulated environment.
• Strong knowledge of GCP, Quality Risk Management, CAPA, Root Cause Analysis, and regulatory requirements.
• Experience with clinical trial processes, CRO/vendor management, and quality/compliance metrics.
• Proficiency with clinical systems, eTMF, eCRFs, quality workflow systems, and Microsoft Office/Excel.
• Strong communication, problem-solving, organizational, and cross-functional collaboration skills.
• Ability to manage multiple projects and travel up to 10%.
• Applicants must be authorized to work in the United States.
  
  

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For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity
PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment
PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations
We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.