Director, GMP Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Support QA Leadership in the creation and implementation of scheduled QA audits that facilitate GMP activities.

• Collaborate with Technical Operations in the selection and oversight of drug substance/drug product contract development manufacturing organizations (CDMOs) for Phase 3 and process performance qualification (PPQ) initiatives.

• Conduct assigned GMP audits independently.

• Work effectively with Technical Operations, offering quality guidance related to GMP data and documentation produced.

• Ensure that manufacturing and testing processes comply with GMP regulations and guidelines, promoting a culture of continuous improvement.

• Manage batch record reviews and releases promptly to ensure an uninterrupted supply for clinical trials and to maintain the consistent production of high-quality products.

• Confirm that manufacturing processes, facilities, and systems comply with current GMP regulations, guidelines, and industry standards.

• Provide QA support for device development activities, such as pre-filled syringes and autoinjectors.

• Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events.

• Stay informed about current regulatory changes and industry trends, translating new requirements into the company’s policies and procedures.

• Apply risk-based quality management approaches to identify and mitigate quality risks across the organization.

• Assist in establishing and reporting key quality metrics to assess performance and drive improvements in GMP compliance and product quality.

• Foster a culture of continuous improvement by identifying areas for enhancement in quality systems and processes to boost efficiency and effectiveness.

• Ensure that employees receive adequate training on GMP requirements and quality procedures.

• Maintain thorough and accurate records and reports pertaining to quality assurance activities.

• Promote a culture of quality within the organization, highlighting the significance of compliance, data integrity, and patient safety.

• Assist in activities that prepare for GMP inspections to support regulatory authority evaluations.

⛳️ Requirements

• A bachelor’s degree in a relevant scientific discipline or equivalent is mandatory; an advanced degree is advantageous.

• At least 10 years of experience in GMP quality assurance within the biotech or pharmaceutical sector, including direct auditing experience and manufacturing of monoclonal antibodies or biologics.

• Familiarity with CDMO oversight, collaborating and aligning on quality matters.

• Experience with Quality Management System Regulations is beneficial.

• Comprehensive knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH standards.

• Proficient in analytical instrumentation, methods, validation, and investigations, including stability program management.

• Extensive experience utilizing electronic QMS for monitoring, reporting, and tracking quality tasks and key quality performance indicators.

• Strong oral and written communication skills, coupled with effective interpersonal abilities to influence and drive change.

• Exceptional problem-solving and critical thinking capabilities.

• Adaptable and innovative to address the needs and challenges of a growing, dynamic organization.

• Commitment to fostering a culture of collaboration and teamwork.

• Capacity to manage multiple projects with tight deadlines and shifting priorities.

• This position requires up to 20% travel, including mandatory in-person attendance at All Hands meetings, typically held twice a year.

🏝️ Benefits

• A vibrant culture centered around our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• The chance to thrive in a fast-paced, highly dynamic environment where you can influence the culture and company, take on various roles, and learn rapidly.

• A competitive compensation and benefits package, featuring a base salary, performance bonuses, equity grant opportunities, and comprehensive health, welfare, and retirement benefits.

• Generous time off policies, including three weeks of PTO, two one-week company-wide shutdowns annually, and dedicated paid sick leave.

• A commitment to your professional growth, with access to resources for further development.

• Regular in-person team meetings to strengthen relationships and collaboratively address challenges.