Sr Manager, GCP Quality Assurance

Sun Pharmaceutical Industries Ltd•Princeton, NJ

3d•$150,500 - $183,500

About The Position

The Sr Manager, GCP Quality Assurance (Asset Lead) provides strategic quality oversight for assigned development programs within Sun Pharma’s Global Development Organization Branded Portfolio within Innovative Medicines. The role is the primary Quality representative to cross-functional global project teams and ensures compliance with applicable GXP regulations, company quality standards, and risk-based quality management principles across the clinical development lifecycle. The position provides quality risk assessments and strategic recommendations, represents QA on clinical and non-clinical teams, and supports compliant, risk-based development activities. It plans, conducts, and reports GCP audits across clinical trial sites, CROs, vendors, laboratories, internal processes, computerized systems, and regulatory submission documentation. The role also supports inspection readiness and inspections, advises on quality implications of development decisions, monitors quality trends, escalates significant risks, and supports implementation of procedures and quality systems for sponsored trials and audit activities. The role requires approximately 20% domestic and international travel, including onsite audits at vendors, service providers, clinical trial sites, and/or internal Sun systems.

Requirements

Bachelor of Science degree in Chemistry, Biology, or a related scientific discipline.
At least 10 years of experience in clinical research, clinical quality assurance, or GxP-regulated environments within pharmaceutical, biotechnology, CRO, or clinical research organizations.
Demonstrated expertise in ICH-GCP, FDA, EMA, ISO, and global regulatory requirements.
Experience supporting regulatory inspections and inspection-readiness programs.
Experience providing quality oversight to Phase I–IV clinical development programs.
Strong risk-based quality management and stakeholder-influencing skills.
Ability to communicate with technical and non-technical colleagues.
Experience establishing and maintaining effective relationships with leaders and peers.
Demonstrated capability as an organizational change agent.
Ability to lead and participate on teams with shared responsibility for outcomes and decision-making.

Nice To Haves

An advanced degree.

Responsibilities

Serve as the primary Quality representative for assigned assets and programs.
Provide quality risk assessments and strategic recommendations to asset teams.
Represent QA on clinical and non-clinical teams, overseeing compliance with regulations, guidance, local laws, applicable ISO standards, TORO, approved protocols and study plans, risk management, safety and product quality reporting requirements, and validated systems supporting patient safety, investigational product quality, and data integrity.
Plan, conduct, and report GCP audits of clinical trial sites, CROs, vendors, laboratories, internal processes, computerized systems, and regulatory submission documentation.
Ensure GCP audit schedules are created and approved by QA management, and create and execute audit plans that ensure compliance with applicable regulations, guidance, guidelines, and standard operating procedures.
Travel to conduct onsite audits at vendors’ facilities, service providers, clinical trial sites, and/or internal Sun systems.
Read, write, and review regulatory submission documents for compliance with regulatory requirements.
Perform for-cause or directed audits when assigned.
Support or lead company inspection-readiness preparations, host inspectors onsite and via remote tools, and serve as Sponsor QA supporting clinical site inspections as required.
Influence clinical development decisions through quality expertise and assess quality implications of protocol amendments, study design changes, vendor strategies, and regulatory commitments.
Collaborate with Outsourcing, Non-clinical, Clinical teams, and functional departments, including clinical supplies and project managers, to support vendor and service-provider selection based on risk evaluation through audit.
Manage complex organizational issues and identify and implement organizational mitigations and/or process improvements.
Escalate significant quality risks to senior leadership.
Monitor quality metrics, audit observations, CAPAs, deviations, and critical quality events to identify emerging trends and risks.
Provide regular reporting to senior management and develop proactive mitigation strategies with functional stakeholders.
Support implementation of procedures and quality systems for GDO-sponsored trials and audits of vendors, laboratories, clinical trial sites, and submission dossiers.