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Company

Original Job Post

Elemental Enzymes · 2 days ago

Quality Manager

St. Louis, MO

Full-time

Hybrid

Senior Level

10+ years exp

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Responsibilities

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

Perform a gap assessment to identify opportunities to enhance the existing QMS.

Lead the effort on new Quality related systems and procedures.

Review and approve master records such as Standard Operating Procedures (SOP’s), Work Instructions (WI), Batch Records (BR), Quality Control (QC) test methods, etc.

Review executed production batch records, environmental monitoring data (as required), QC testing results, and associated documentation, including any trends, deviations, and investigation reports related to product disposition, ensuring compliance of the whole product specifications for commercially released lots.

Perform Product Disposition and Lot Closure using enterprise resource planning (ERP) programs.

Oversee the release of raw materials from quarantine.

Ensure process control measures are in place and followed in product manufacturing.

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

Provide Quality oversight to the equipment management lifecycle, including initial qualification, preventive/predictive maintenance and calibrations, and decommissioning.

Oversee process validation and ensure proper handoff of product and process development packages from process development team to manufacturing.

Oversee QC method transfer to both internal and external testing labs.

Provide QA oversight and review of internal deviations. 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 executed in a timely manner. Oversee CAPA effectiveness checks

Provide quality oversight and support for new product introductions as primary quality point of contact.

Provide QA oversight of the training program.

Support other QA activities as assigned.

Promote Quality as a Culture using QMS and QRM for data-driven decisions.

Create and maintain programs for high-quality products and compliance.

Write, review, and approve controlled documents under QMS.

Ensure quality objectives are met.

Administer the quality supplier management program.

Address quality-related customer questions and concerns.

Collaborate with R&D, Process Development, Manufacturing, Regulatory Affairs, and Commercial teams.

Manage product and process changes through the MOC process.

Lead internal/external inspections and audits.

Track and trend KPIs for QMS and QA department.

Generate and report data for leadership.

Foster a Quality culture by leading through example.

Identify QA functional needs and develop solutions.

Attract, develop, and retain a high-performing team.

Lead the department in achieving individual and departmental goals.

Qualification

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Quality systemsIso 9001Electronic qmsSalesforce saasEnvironmental healthOccupational healthIso 14001Iso 45001Gmp standardsBiotechnologyAuditsAsq cqaProduct developmentProject implementationAccountableRegulatory guidanceProblem-solvingHard-workingEffective communicationAnalytical skillsTeam playerIndependentAdaptableASQ CQA certificationISO 14001/4500121 CFR 21121 CFR 820Onsite rolePPEBiosafety Level 2 Laboratory

Required

Expert knowledge of Quality Systems and ISO 9001 QMS.

Experience with electronic QMS, preferably Salesforce SaaS.

Knowledge of Environmental and Occupational Health and Safety systems, ISO 14001/45001 preferred.

Familiarity with GMP standards (e.g., 21 CFR 211, 21 CFR 820) for biotechnology.

Experience leading audits, ASQ CQA preferred.

Product development experience beneficial.

Bachelor's degree in biological sciences, engineering, or related field, and 10+ years of experience in pharmaceutical, biotech, or biologics operations.

Ability to work on complex, non-routine assignments.

Effective participation in cross-functional teams.

Strong planning, organization, and project implementation skills.

Detail-oriented, accountable team player with quality assurance expertise.

Excellent communication and analytical skills.

Independent, self-starter comfortable in a fast-paced environment.

Ability to interpret and apply procedural and regulatory guidance.

Adaptable to changing priorities.

Preferred

ASQ CQA certification.

Experience with ASQ CQA.

Product development experience.

Experience with ISO 14001/45001.

Experience with 21 CFR 211, 21 CFR 820.

Experience with GMP standards for biotechnology.

Onsite role with potential for hybrid or remote work. Up to 20% travel required.

Physical Requirements: Reaching, standing, and lifting up to 50 lbs. Must wear required PPE, including respirators. Repetitive motion of wrists, hands, and fingers. Possible work in Biosafety Level 2 Laboratory.