Title:  Vice President, and Head Development Quality Assurance, Branded Portfolio

Head, Development Quality Assurance, Branded Portfolio 

The Head Development Quality Assurance will drive Quality Culture with Branded Portfolio Development stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities.  The incumbent will be responsible for managing business relationships with defined stakeholder groups and senior leaders in Development and for the strategic development and delivery of a GCP/GxP risk based robust quality management activities for these stakeholders.

Responsibilities

• Serve as the strategic leader to drive, direct, oversee and manage quality and compliance across all Development functions.
• Drive the design, analysis and oversight of global, phase appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S., EU and ROW.   
• Provide leadership, direction, across all levels of the organization to assure quality assurance strategies are known and implemented.
• Lead a multifunctional Development Quality team for clinical quality oversight for the entire spectrum of development functions.
• Represent DQA on Global Program Teams and Regulatory Strategy Teams to identify quality risks and mitigation strategies.
• Identify Key Quality and Risk Indicators (KQIs/KRIs) and oversee mechanisms for detection and trending.
• Liaise with the Heads of Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacology, Biostatistics and Data Management as needed for the clinical studies.
• Collaborate with cross-functional management to drive DQA process improvements and alignments
• Ensure quality is maintained with CRO at all stages of development
• Guide quality investigations, facilitating investigations, and Root Cause Analysis
• Ensure inspection readiness for assigned programs, including training and tracking commitments
• Develop and administer budgets, plans, and performance requirements linked to the clinical quality assurance department.
• Participate in interview, induction, and training and performance evaluation of all DQA leads.
• Ensure that the development teams adhere to the principles, guidelines and best practices of the QA strategy as defined

Qualifications

• Master of Science, Master of Pharmacy, Ph.D or similar degrees
• Must have 20 years’ experience in GxP Quality Assurance in innovative drug development domains
• Expertise in GxP/GCP regulations and guidelines (EMA, FDA, PMDA, etc.)
• Significant experience in GxP investigations, risk assessments, and CAPA management
• Participation in regulatory inspections.
• Proficiency in mentoring and team management

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun Pharmaceuticals (Sun).  No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.