Sr. Director, Quality Assurance GMP

Position Overview

Nektar has an exciting opportunity for a Sr. Director, Quality Assurance GMP to join their QA team.

The Sr. Director, Quality Assurance GMP is responsible for providing leadership for all GMP Quality Assurance activities at Nektar San Francisco, and, in collaboration with other corporate QA leadership and all GMP activities across the company.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Establish and manage GMP policies and procedures to ensure that products are developed, manufactured, and packaged consistent with appropriate regulations and requirements.
• Develop and implement contemporary, phase-appropriate quality systems and practices that ensure appropriate metrics and process indicators to drive compliance and continuous improvement.
• Manage interactions with regulatory agencies during compliance inspections.
• Work in collaboration with departments to develop and ensure readiness for inspections.
• Establish and manage appropriate policies and procedures to ensure ongoing regulatory compliance for clinical and commercial products.
• Develop and implement appropriate regulatory systems to ensure required communication with FDA, or other regulatory bodies, are maintained (e.g., adverse event reports, annual product reviews, annual reports, field alert reports, recalls, supplements, and advertisement and promotional labeling changes).
• Assist marketing partners with foreign regulatory filings.
• Provide input and guidance to CMC development activities to ensure robust data packages to support regulatory submissions.
• Work to establish processes and systems that support collaboration and compliance across an extended partner network.
• Provide leadership for intra-company quality teams in support of corporate collaborations.
• Support the evaluation/selection potential future contract manufacturing organizations (CMOs).
• Ensure quality agreements are in place at CMOs to ensure adherence to regulatory requirements.
• Provide quality input in technology transfers to CMOs.
• Ensure quality assurance procedures (e.g., change control, investigations, CAPAs, OOS/OOT) are adhered to at CMOs, and, if needed, assist in resolution of associated issues.
• Oversee internal and external audits for GMP activities.
• Lead investigations and resolve potential product quality issues to improve efficiency.
• Responsible for overseeing the review of data and release of all clinical and commercial products and ensure that the product characteristics meet appropriate quality specifications and regulations/guidelines.
• Oversee review and approval of procedures, production records and specifications.
• Represent Quality Assurance on cross-functional project teams.
• Work with abstract ideas or situations across functional areas of the business on complex issues where analysis of situations or data requires an in-depth knowledge.
• Interact internally and externally with executive level management, requiring negotiation of extremely critical matters.
• Participates in corporate development and evaluation criteria for projects, programs, and personnel.
• Responsible for hiring and managing internal and external personnel.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function.
• Provide direction and leadership to staff. Establish realistic goals and objectives.
• Plan, direct, and monitor work activities such that goals and objectives are accomplished efficiently, completely, within established timeframes, and in compliance with department SOPs and cGMP regulations.
• Ensure training of all GXP personnel.

REQUIREMENTS

BS degree, or equivalent, in a pharmaceutical-related field with a minimum of 15 years experience in Quality and/or manufacturing support, including at least 10 years of supervisory experience. Experience with electronic documentation management systems. Extensive internal and external auditing experience. Comprehensive knowledge of current Good Manufacturing Practices and the ability to correctly interpret cGMP minimum standards. Working knowledge in quality sciences, statistics, and computer-based operations. Strong verbal and written communication skills are required.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.