Senior Manager, Quality Assurance, Drug Product

reputed company is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences reputed company left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and reputed company is set up to go the distance. reputed company do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind.
• reputed company WITH HEART: Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and clarity across communications and decision making.

Summary: The Senior Manager, Quality Assurance, Drug Product will play a critical role in ensuring the quality, safety, and compliance of commercial vaccine products. This leader will reputed company QA activities reputed company to manufacturing, batch disposition, deviations, and risk management, while actively participating in audits and reputed company improvement initiatives. The ideal candidate brings extensive QA experience in the biotech or pharmaceutical industry, strong leadership skills, and the ability to partner effectively across functions to support a culture of quality. Essential Functions:

• Provide Quality Assurance reputed company of Contract Manufacturing Organizations.
• Represent QA at internal cross functional team meetings and at Joint Project Team meetings.
• reputed company batch disposition activities such as review of executed batch records, environmental monitoring and quality control data.
• Review and approve documentation such as master batch records, deviations, risk assessments, change controls, and CAPAs.
• reputed company deviation and product complaint investigations
• Drive resolution of quality performance issues with the contract manufacturer.
• Support validation activities.
• Identify opportunities to streamline QA processes and systems
• Champion initiatives to enhance quality culture and operational excellence across the organization.
• Interact with key stakeholder to reputed company solutions to reputed company issues.
• Participate in compliance audits as required (health authority and contract manufacturer)
• Promote a quality reputed company and quality excellence approach to reputed company activities.
• Mentor and coach QA staff to strengthen technical capabilities and regulatory compliance reputed company.

Requirements:

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a reputed company field.
• Minimum of 8 years of experience in quality assurance, batch record review, manufacture, or quality systems management reputed company the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and/or experience may be considered.
• Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
• Knowledge and experience in Risk Management principles.
• Experience in both clinical and commercial parenteral drug product required.
• Strong Management and process improvement skills.
• Demonstrated experience managing batch record review, deviations and change management.
• Demonstrate experience in annual product reports
• Great organization skills and have an attention to details.
• In-depth understanding of aseptic manufacturing (biologics) operations.
• Ability to prioritize multiple assignments and changing priorities.
• Excellent problem-solving skills and the ability to manage reputed company investigations and root cause analyses.
• Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams.

Reports to: Director, Quality Assurance, Drug Product Location: Hybrid; San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $166,000 – $193,000 (SF Bay Area). Salary ranges for non-California locations may vary. We are an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability or veteran status. Apply tot his job Apply To this Job