Senior Quality Engineer

MissionHires is seeking a Senior Quality Engineer on behalf of a fast-growing online pharmacy company to provide quality and compliance oversight for pharmaceutical manufacturing and wholesale operations. This role partners closely with Engineering, Production, and Supply Chain to ensure operations meet applicable FDA, state, cGMP, and USP requirements. The Senior Quality Engineer will lead quality activities, approve engineering and validation documentation, support audits and supplier quality, and drive continuous improvement across the quality management system.

• Partner with Engineering, Production, and Supply Chain teams to ensure manufacturing and wholesale operations comply with applicable laws, regulations, site requirements, and quality standards.
• Serve as a technical quality expert, providing consultation, practical solutions, and compliance guidance to cross-functional stakeholders.
• Manage and support quality and compliance activities, including deviations, audits, customer complaints, escalations, and related investigations.
• Act as a Quality approver for Engineering and Validation activities.
• Author, review, and approve quality documentation, including regulatory communications, product specifications, policies, procedures, and records.
• Interpret and apply FDA, state, and industry requirements and best practices across operations.
• Provide Quality Management System oversight for ACE and the training program.
• Support the qualification, approval, and ongoing maintenance of suppliers.
• Collect, analyze, and communicate quality and operational data to identify risks, trends, and improvement opportunities.
• Maintain accurate, complete, and inspection-ready records and documentation.
• Build strong customer service relationships with internal and external stakeholders.
• Lead quality projects and cross-functional workstreams as needed.
• Train, orient, and review the work of peers to support consistent quality practices.

• Bachelor's degree in Engineering, Life Sciences, or a related field, or equivalent years of directly related experience; a graduate degree is preferred.
• At least 5 years of relevant experience in an FDA-regulated environment.
• Extensive knowledge of aseptic filling and pharmaceutical compounding.
• In-depth knowledge of cGMP requirements, including USP <797>, 21 CFR Part 211, and applicable guidelines, policies, and procedures.
• Knowledge of FDA and USP sterile and non-sterile compounding requirements.
• Experience with deviation management, audit handling, customer complaint handling, escalation management, and quality documentation.
• Ability to review and approve engineering, validation, and quality-system documentation.
• Strong understanding of audit processes and supplier quality management.
• Project management proficiency and/or experience with Operational Excellence methodologies.
• Strong data analytics, critical-thinking, problem-solving, and decision-making skills.
• Demonstrated ability to train, orient, mentor, and/or review the work of peers.
• Commitment to exceptional quality and compliance standards without compromising customer expectations or regulatory requirements.
• Excellent written and verbal communication skills.
• Computer proficiency in Windows and Mac environments and related computer systems.
• Ability to work independently with minimal supervision.
• Applicable industry or professional certification is preferred.
• Regular and predictable attendance.

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