Senior Manager Quality

What We Do:

Ambrx Biopharma, Inc. is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

How will you contribute to our mission:

We are looking for an experienced Senior Manager of Quality to support our quality management systems at Ambrx. The role is responsible for quality oversight of clinical development and batch disposition. The Senior Manager works with internal functional groups and CMO/CDMOs to support global activities, ensuring that our products meet regulatory requirements and industry best practices.

• Responsible for serving as the Quality Unit reviewer/approver on SOPs, protocols, and other assigned documents.
• Serve as the process owner for all GxP Training within Ambrx, including development of internal training SOPs, forms, monitoring compliance to plans, creation of metrics, and continuous improvement of the training system.
• Support and/or perform batch disposition by reviewing executed batch-related documentation and ensure proper resolution of quality issues.
• Ensure all product-related deviations are initiated, investigated, and properly addressed to assure product quality.
• Reviews batch related documentation necessary to support product release and stability data for in-process and finished products, including manufacturing batch records, environmental monitoring data, quality control records, deviations, change controls and other batch documentation.
• Provide QA support for tech transfer, scale-up and validation.
• Provide QA for QC activities including method transfer, method verification and qualification.
• Implements and maintains systems and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), Good Distribution Practices (GDP) and Good Clinical Practices (GCP).
• Conducts risk assessments, root cause analyses, and continuous improvement initiatives to identify and address quality-related issues and deviations.
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements in support of Clinical and Commercial programs.
• Collaborate with cross-functional teams, including Research and Development, Manufacturing, Regulatory Affairs, Supply Chain, and Clinical to ensure seamless integration of quality standards throughout the product lifecycle.
• Participates and supports Quality leadership during regulatory and customer audits/inspections.

What you will need for consideration:

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree (e.g., Master's or Ph.D.) preferred.
• Requires minimum of 5-10 years of experience in GMP quality management within the preferably in the pharmaceutical or biotech industries or related field or equivalent, with at least 2 years in a leadership role.
• In-depth knowledge of cGMP, ICH, FDA, EMA, and other global regulatory requirements.
• Strong understanding of biologics and pharmaceutical manufacturing processes.
• Proven experience in managing cross-functional teams and driving quality initiatives.
• Excellent problem-solving and critical-thinking skills. Gathers and analyzes information skillfully.
• Excellent interpersonal skills, including listening, writing, negotiating positions, facilitating discussions, possess great attention to detail.
• Ability to work effectively in a fast-paced, dynamic environment.

Preferred Skills:

• Previous experience with Antibody-Drug Conjugates is a plus.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
• Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

Pay Scale:

The pay scale for this position is: $160,000- $195,000  commensurate with experience. We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.

As an equal opportunity employer, Ambrx is committed to a diverse workforce. Ambrx will consider all qualified applicants without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

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