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Associate Director, Quality - Healthcare/Consumer Care Programs
The Associate Director, Quality position is a leadership role responsible for all quality aspects of manufactured products from design through delivery at our CMO (contract manufacturing organization) for a portfolio of products in the healthcare and consumer care verticals. It will include aspects of quality management and administration, supplier quality, development quality and technology transfer, often to fully compliant cGMP environments. This position will be the point of accountability and key responsible partner for quality with operations teams on launching products and managing supply chain quality.
Job Description and Specific Responsibilities
General Quality Management and Administration
- Provide technical leadership, mentorship and generally help enhance the competencies of other departments.
- Able to manage cross-functional teams to develop end to end requirements to launch quality products and transfer to CMO’s
- Drive other projects as needed by executives or as business needs change.
- Build small team to manage all quality needs for healthcare / consumer care product verticals
Internal Development Projects
- Ensure proper certification and testing completion prior to each phase of production (e.g. proper documentation for delivery of a GMP certified strain).
- Collaborate with development team members on FMEAs and PFMEAs on new products.
- Along with members of the calibration and lab management teams to ensure the validation/qualification of inspection tools, gauges and chambers used in the Zymergen GMP environment to meet or exceed Zymergen and industry standards.
- Review/Approval of protocols, reports and any deviations required as a result.
- Work closely with development and strategic sourcing to establish strategic directions of Supplier and Product Quality initiatives.
- Conduct assessments of potential suppliers to assist Development, Purchasing & Strategic Sourcing partners in determining sources for components and systems.
- Along with members of the development and calibration teams ensure validation of inspection tools and gauges at suppliers in order to determine if they are technically qualified to meet or exceed Zymergen and industry standards.
- Set supplier performance metrics and take ownership for supplier quality performance results.
- Manage the relationship between Zymergen and suppliers relative to quality performance and trends.
- Monitor, driving and optimizing inspection frequency based on historic inspection results.
- Issue and manage the timely resolution of supplier corrective and preventive actions (SCARs) as identified by audits, performance issues, trend and/or non-conformances.
- Verify compliance to QMS requirements and the effectiveness of the supplier’s quality systems by performing supplier audits and surveys.
- Document audit results via a professional report / scorecard system that can be shared with development, purchasing and strategic sourcing partners.
- Develop and implement a Supplier Improvement Program to ensure compliance with Zymergen and industry standard.
- Ensure proper certification and testing completion prior to each phase of production at suppliers.
- Provide input to maintain the Approve Supplier List (ASL) to document supplier certification and qualification status and to preclude non-approved supplier being used.
- Develop, maintain, and improve supplier quality procedures such as assessments, audits, corrective actions, early production containment, proof of capacity, receiving inspection, score cards.
- Drive continuous improvement (quality /delivery / cost) throughout the supply base using lean manufacturing and proven quality management methods.
- Development and preparation of Quality reports for various Zymergen teams and Executive Management as well and Suppliers on a timely basis.
- 5+ years experience in the Quality / Supplier Quality field in life sciences, predominantly in a GMP environment.
- 5+ years experience in defining, structuring and implementing quality tools and systems.
- 4 years of experience in management roles in quality assurance and/or quality control
- Must be versed in CFR parts 210 and 211, with similar experience in EMEA, ICH, or ISO 13485 applicable.
- Experience in EPA, USDA-regulated businesses is a plus.
- Lean and/or Six-Sigma experience a plus.
- GMP, Pharma, Biotech, Life Science experience a requirement.
- Must be able to travel domestically and internationally
Legal authorization to work in the U.S. is required. We are not able to sponsor individuals for employment visas for this job. Must be able to travel domestically and internationally.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Founded in 2013 and based in the San Francisco Bay Area, Zymergen is a technology company unlocking the power of biology. We deliver better economics for products made from biology that are used across industries, bring new products to market faster, and develop novel products. Our proprietary platform uses robots and machine learning to engineer microbes faster, more predictably, and to a level of performance previously unattainable. These microbes, and the products they produce, have broad applications across industries such as chemicals and materials, agriculture, and healthcare. For more information visit www.zymergen.com.
Zymergen at a glance
Zymergen focuses on Robotics, Machine Learning, Software, and Big Data Analytics. Their company has offices in San Francisco Bay Area and Emeryville. They have a large team that's between 501-1000 employees. To date, Zymergen has raised $576M of funding; their latest round was closed on December 2018.