Sr Manager, GCP Quality Assurance

The Sr Manager, GCP Quality Assurance (Asset Lead) provides strategic quality oversight for assigned development programs within the Sun Pharma Global Development Organization (GDO) Branded Portfolio within Innovative Medicines.  The role serves as the primary Quality asset 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.

Key Responsibilities:

• Serve as the primary Quality representative for assigned assets/programs.
• Provide quality risk assessments and strategic recommendations to asset teams.
• Represents QA on the clinical and non-clinical teams; Quality Assurance oversight ensures compliance to regulations, guidance, local laws, and applicable ISO standards, TORO, approved protocol, study plans, risk management, safety and product quality reporting requirements and use of validated systems for patient safety, investigational product quality, and data integrity. 
• Plans, conducts, and reports GCP audits of clinical trial sites, CROs, vendors, laboratories, internal processes, computerized systems, and regulatory submission documentation in accordance with applicable regulations and procedures.
• Ensures that the GCP Audit schedules are created and approved by QA management; create and execute audit plans that ensure compliance to applicable regulations, guidance/ guidelines, and standard operating procedures. 
• Able to travel to conduct audits onsite at vendors’ facilities, service providers, clinical trial sites, and/or internal Sun systems.  Proficient to read/write/review written regulatory submission documents to ensure the content is compliant to regulatory requirements. Performs For-cause/Directed Audits when assigned. 
• Supports/ Leads company inspection readiness preparations and hosts inspector onsite and via remote tools; Serves as Sponsor QA to support Clinical Site inspections, as required
• Influence clinical development decisions through quality expertise. 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 the selection of vendors and service providers based on risk evaluation thru audit; manage complex organizational issues, identify and implement organizational mitigations and/or process improvements. 
• Escalate significant quality risks to senior leadership. Monitors quality metrics, audit observations, CAPAs, deviations, and critical quality events to identify emerging trends and risks. Provides regular reporting to senior management and develops proactive mitigation strategies in collaboration with functional stakeholders.
• Support the implementation of procedures and quality systems used to support the GDO Sponsored trials and for audit conduct of vendors, labs, clinical trial sites, and submissions dossiers.
• Travel requirement is 20% domestic and international

Requirements:

• BS Degree in Chemistry, Biology, or related scientific discipline; advanced degree preferred.  A minimum of 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 organizational change agent. Ability to lead and participate on teams with shared responsibility for outcomes and decision-making. 

The presently-anticipated base compensation pay range for this position is $150,500 to $183,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.