Quality Manager

The Quality Manager will lead the Quality Assurance and Quality Management Systems functions within the Manufacturing division and will provide oversight to ensure compliance with applicable quality objectives and regulatory requirements within the Quality department. This role will be responsible for developing the function while leading day to day operations. This is an exciting opportunity to join a rapidly growing Biotechnology company and have influence on creating strategic, tactical, and operational plans that align with the company’s strategic growth aspirations.

The Quality Manager will have responsibilities in the following areas:

Product & Process:

• Oversee the daily activities of the Quality Assurance (QA) department and administration of the Quality Management System (QMS).

• Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any trends, deviations, and investigation reports related to lot release of product disposition ensuring the compliance of the whole product specifications.

• Review manufacturing, environmental monitoring, and quality control data for in process and finished products.
• Oversee the Quality Risk Management (QRM) program.
• Perform Product Disposition and Lot Closure using enterprise resource planning (ERP) programs.
• Oversee the release of raw materials from quarantine.
• Provide oversight of the supplier management program.
• Track and respond to quality-related customer questions and/or concerns.
• Ensure process control measures are in place and followed in product manufacturing.
• Provide quality oversight of the calibration and preventive maintenance programs.
• Work with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
• Approve process and equipment qualifications and validations and ensure proper handoff of product and process development packages from process development team to manufacturing.
• Manage the product and process change management ensuring product quality is not impacted with any product/process proposed changes.
• Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated, and resolved in accordance with established disposition timelines.
• Provide QA oversight and approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
• Manage and monitor CAPAs for successful completion and successful implementation.
• Provide quality oversight and support for new product introductions as primary quality point of contact.
• As assigned, manage, and provide QA oversight for other processes, including training.
• Support Lean Manufacturing principles to ensure process-in-control.

Quality Systems:

• Oversees the development and review of Standard Operating Procedures (SOPs) to ensure quality objectives are met within the organization.
• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
• Interact with key stakeholders such as R&D, Process Development, Manufacturing, Regulatory Affairs, and Commercial to ensure that Products are manufactured in accordance with established procedures and appropriate regulations.
• Manage the tracking of deviations, CAPAs, and audits.
• Manage all product and process change proposals and executed changes through a Management of Change (MOC) process.
• Create and maintain programs and processes to ensure high quality products and compliance with current best practices, using ISO9001 as a guiding tool.
• Lead and participate in internal/external inspection and audits.
• Establish and track metrics related to product disposition in support of the Management Review.
• Generate and report data for leadership.

Leadership & Management:

• Create a Quality culture by leading through example.
• The Quality Manager will be responsible for identifying the QA function needs, and developing solutions to those needs, including the personnel necessary to have a world class Quality Assurance team.

• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training, and development, coaching and mentoring and performance management.
• Lead department in successful completion of individual and departmental goals.

Knowledge, Experience, and Skills:

• Expert level knowledge of Quality Systems, specifically ISO 9001, is required.
• Good working knowledge of Environmental and Occupational Health and Safety systems, such as ISO 14001 and 45001, is required.
• Good working knowledge of Good Manufacturing Practices standards applicable to biotechnology is preferred.
• Expert level knowledge on performing and leading audits
• Experience working on product development is beneficial.
• Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors.
• Ability to effectively participate in cross-functional teams.
• Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives.

• An accountable team player who is detailed and quality oriented with solid understanding of quality assurance principles, systems, and procedures.
• Excellent attitude with strong verbal, written, and interpersonal communication skills.
• Self-starter, able to work independently.

Basic Qualifications/Requirements:

• Bachelor’s degree in the biological sciences, biological/chemical engineering or related field and 10 years of progressive experience in a food manufacturer, chemical manufacturer and/or, biotech, or biologics operation, or equivalent education/work experience
• Masters/PhD in a scientific program working on developing new products is preferred.
• Expert knowledge of ISO 9001 Quality Management Systems is required.
• Working knowledge of ISO 14001/45001 EHS and OHS Systems is required.
• Good working knowledge of ERP Systems, e.g., SAP, NetSuite, etc. is required.
• Prior experience in food, biotech or pharmaceutical, and/or regulated chemical industry is desired.
• Good working knowledge of Good Manufacturing Practices, based on FDA 21 CFR, is preferred.
• Strong knowledge of Six Sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Ability to interpret and apply procedural and regulatory guidance in potentially ambiguous.
• Ability to understand risk and provide phase-appropriate decisions.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Candidates must have good interpersonal skills, strong written communication skills and strong analytical skills.
• Comfortable in a fast-paced small company environment and operate with minimal direction.
• Ability to adjust workload based upon rapidly changing priorities.

Job Location: St. Louis, MO, United States

Position Type: Full-Time/Regular/Salary/Exempt

Salary: Competitive base range

Benefits: 401K, Healthcare, Dental, Vision, Life Insurance, HSA/FSA Options, Employee Assistance Program, Short-Term Disability, Long-Term Disability, Pet Insurance, Accident Insurance, and Dependent Care Account

About Elemental Enzymes

Elemental Enzymes was founded upon the simple belief that we must do everything we can to improve agricultural performance in a way that not only enables plants to flourish but enriches and renews the planet with eco-friendly and sustainable agricultural solutions. From products that enable effective enzyme, peptide and protein inputs to foliar treatments that hold the promise to renew entire industries, our focus to make a positive difference in the world through people – like you and me. Success is a byproduct of responsible production. That’s why Elemental Enzymes works to bring cross-disciplinary scientists and processes together to create novel solutions to practical problems with a shared goal of helping both the plant and the planet.

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Please fill out the application and attach a cover letter and CV/Résumé. References required upon request.