QA Manager, Compliance

Job Summary

This role focuses on data compliance during product testing and manufacturing of Alexza/Ferrer’s device and drug products for clinical and commercial products. Assures compliance to requirements from FDA 21 CFR, ISO 13485 and ICH Q10. This is accomplished through generation and review of documents used in Good Manufacturing Practices as well as regulatory compliance in all areas governed by cGMP regulations (e.g., Production, Packaging, Quality Control, Warehousing, and Distribution). May lead investigations and resolve potential product quality issues from QC testing and manufacturing processes. This role contributes to and supports Alexza/Ferrer’s readiness for clinical and commercial distributions.

Responsibilities

• Receive assignments in the form of objectives and determines how to tactically meet these goals and manages work priorities to ensure the expedient review and release of drug products.
• Manage product release process including batch record reviews and QA oversight of analytical data supporting product testing and stability testing.
• Manage data integrity review of source documentations for NDA, BLA submissions.
• Manage the Complaint Handling process by liaising with Partners, issuing, reviewing and approving investigations in DOT.
• Manage the process for improvement initiatives such as impact assessment of standards and regulations. Initiating CAPA or change control to address impact.
• Manage DOT workflows and metrics for Nonconformance Reports, CAPAs, change controls, complaints and other quality records associated with Alexza’s
• Manage meeting logistics for MRB, CRB, CCB.
• Produce and maintain Quality KPIs for presentation in Quality Review Board and Management Reviews.
• Provide Quality guidance and assure the compliance to Alexza’s procedures and/or regulatory requirements related to Alexza’s product.
• Participate in internal and external audits, including management of audit support room.
• May review validation protocols and
• Write and revise standard operating procedures for quality improvement
• Develop and maintain productive working relationships with Functional
• Work on problems of diverse to complex scope in which analysis of situation or data requires evaluation of a variety of factors.
• SME for DOT compliance electronic Quality Manage System modules, NCR, CAPA, change control, etc
• Potential for 1-2 direct reports.

Skills required

• Strong written and verbal communication, organizational and prioritization
• Ability to handle multiple priorities in a project driven environment.
• Ability to work and coordinate activities with multiple functional groups with sense of urgency.
• Ability to maintain a flexible and customer-oriented approach to problem-solving.
• Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results. Decisions affect ability to achieve project deadlines, quality, and/or success.
• Ability to maintain detailed and accurate records.
• Familiarity with electronic Quality Manage Systems, (DOT compliance, Veeva, Trackwise etc)

Education and experience

• BS in scientific or related
• Minimum 5-10 years cGMP experience in Quality Assurance
• Industry experiences in medical devices ISO 13485 and/or FDA 21 CFR regulations for Drug Product
• Experience with managing audits or inspections.
• Proficient in the use of a wide variety of computer applications including the MS office, Excel, data base management systems, and project management software

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

The annual base salary for this role starts at $164,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. The initial base salary is just one component of Ferrer’s total compensation and benefits package, which includes, but is not limited to, discretionary bonus plan; life, health, accident and disability insurance; and a 401(k) plan.

Who We Are

At Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.

Alexza Pharmaceuticals is part of Ferrer and is an R&D and Manufacturing center located in Fremont, CA. Our focus is to develop technologically advanced, forward-thinking and innovative products for our pipeline based on the Staccato One Breath Technology. We research, develop and manufacture novel, proprietary products for the acute treatment of underserved medical needs.

Why Alexza/Ferrer

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing