Quality Assurance; QMS) Manager - ISO - GMP - FDA

Quality Assurance (QMS) Manager - ISO
9001 - GMP- FDA

This is an exciting role created to unify the Quality Assurance efforts and compliance for GMP and FDA standards, as well as maintain ISO-9001. You’ll lead non-conformance investigations, auditing for internal systems, and external suppliers. Travel a bit to other manufacturing sites in the USA. If you are looking for an established company with plans for growth, this could be an amazing new home!

Direct the Quality program for all U.S. locations. Maintain suitable and effective Quality Management System based on ISO 9001, USP and GMP principles. Provide support to Engineering, Commercial, and Production teams in solving internal and external quality, technical and engineering related issues. Manage customers’ complaints & other quality issues for all U.S. locations.

• Direct the preparation and submission of all required reports to auditing and regulating agencies.
• Responsible for preparing all customer & internal quality complaint-related reports as required by management.
• Review and approve all monthly Quality reports from all facilities for executive leadership team.
• Heads internal investigations into customer complaints and non-conformances as well as directing external investigations with customers into application problems to determine potential solutions.
• Travel to customer sites review customer operations and product requirements as required.
• Develop a supplier audit schedule annually and execute to the schedule. This will be a combination of paper, virtual and in person audits based on the role and size of the supplier.
• Partner with customers to successfully integrate company product into customer processes.
• Support Quality and Technical Department investigations into customer application issues as well as internal instrumentation problems as needed.
• Conduct quarterly compliance audits for all US based facilities.
• Complete customer quality surveys and be the point of contact for customer audits and US based facilities.
• This position requires monitoring production and other data to ensure all transactions meet all applicable quality regulations and requirements.
• Is authorized to release API grade products when the Quality Control Manager is not available for release approval.
• Create effective control structures that ensures not only legal compliance but more importantly the quality of all products and protection of the environments in which we operate.
• Partner with all levels of management to implement the structure creating and sustaining a culture where quality compliance is not only valued by expected.
• Responsible for reviewing new systems and processes to make sure proper management of change is documented and that there will be no impact to customer quality or determine if a customer needs to be notified of the change as it may impact the quality of material that’s they receive.
• Responsible for domestic and global compliance to Quality requirements; conduct or direct all quality activities, and compliance with any new laws.
• Other duties assigned by management.

Salary $120,000 - $140,000 + Bonus

• Benefits 401k, Vacation, Full suite of insurances, Safe Harbor contribution, Tuition Reimbursement, and more!

• Quality Management & Engineering with hands‑on experience with ISO 9000, USP and GMP systems
• Competence in statistics and mathematics as used for quality control & assurance (SPC SQC)
• Experience in conducting Internal Audits as well as handling External Audits
• Supervisory experience in operating chemical test labs and lab personnel
• Ability to train others
• Extensive knowledge of the quality requirements of ISO and other global standards, as well as the experience in developing and implementing…