Assocaite Director, Quality Assurance

• Technical review and approval of Process and Analytical Protocols/Reports, Manufacturing Process Documentation, and clinical trial documentation for compliance with GxPs and ICH guidelines
• Proactively monitor compliance of the companies outsourced activities with respect to company procedures as well as FDA, EU, ICH, PMDA and other regulatory expectations and requirements
• Support implementation of all strategic Quality initiatives across all company cross-functional areas and global office sites and provide adept supportive leadership.
• Ensure that the company operates in a manner which is fully compliant with applicable GxP’s and international standards resulting in minimal audit findings for outsourced contract partners and from Regulatory Agencies.
• Oversight of diligent and timely close-out of product investigations, complaints, deviations associated with release of commercial and clinical material.
• Manage and support effective Quality oversight of the companies Vendor Management Program.
• Provide QA oversight and critical evaluation of all outsourced Validation / Qualification activities.
• Review and approve CMC sections of Regulatory filings on behalf of Quality function.
• Identification and resolution of quality, process and analytical issues associated with technology transfer and Validation / Qualification activities.
• Oversight and review of partners i.e., CDMO/CTL/CRO and where appropriate, manage these relationships through annual vendor review.
• Support CMC/Manufacturing/Clinical and regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets.

• Support all Quality and compliance relations with PMDA, FDA and other related health authority agencies.
• Support the rollout and implementation of the global training programs.
• Identify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with senior management throughout the company.

Person Spec

• Educated to degree/masters’ level in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation.
• An advanced degree desirable. Very good knowledge of Quality Operations (Clinical and Commercial), Quality regulations particularly in US, EU and Japanese markets.
• Minimum 10-15 years’ experience gained in a pharma manufacturing environment role, minimum of 5-10 yrs. at Senior Manager level.
• Experience with regulatory interactions preferably with FDA, EMA and PMDA
• Preferably prior experience with both small molecule and biologics drug development
• Comprehensive knowledge of current US and ex-US regulatory guidelines
• Excellent knowledge of Regulatory Compliance, process and analytical validation and technical transfer. Has a thorough understanding of US and international regulatory requirements as they pertain to general Quality.
• Has a thorough understanding of the regulatory process from IND through commercialization.
• Strong project management skills
• Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development and Quality Control
• Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
• Strong written and oral communication skills.
• Able to grasp complex technical issues and make sound decisions based on data and information from various sources.
• Ability to foster and promote internal collaboration.