Our client is in search of a Sr. Plant Manager of Quality
Why is This a Great Opportunity?
Great opportunity for a Quality Manager with experience in OTC drugs or medical device industries to lead a team of Quality and Microbiology professionals. The positions will provide direction in supporting development of a QA Organization. This is a key leadership role and interfaces and collaborates with all senior management within the plant. The role is responsible for delivery of quality metrics, KPI's and on-going improvement of systems and capability.
- Lead compliance adherence and improvement at the plant site. Responsible to achieve satisfactory or better compliance on a daily basis as well as during all external audits.
- Regular FDA (OTC, MD, Cosmetics) , ISO 13485, and TUV audits – avoiding issues and disruptions to the business.
- Maintain capability within the plant to successfully host regulatory agencies and registration body audits.
- Leads proactive and on-going improvement of Plant QA/QC work processes, systems (QMS), and results. Partner with the Plant Leadership Team on providing cross functional expertise supporting quality work process development (the what, why, and how).
- Maintain excellence and high standards in quality work processes, systems, and results within the plant.
- Lead development and delivery of plant quality goals consistent with agreed company metrics.
- Set direction for and ensure Hygiene capability is developed and maintained within the plant
- Train, sustain, and improve the health of quality systems at the plant
- Support supplier quality through data gathering, feedback, and audits as needed.
- Manage QA budget and Capital spending. Develop and deliver against spending and productivity improvement goals.
- Partner with Plant Operations VP to ensure Plant Quality culture is clear and understood.
- Lead the Plant QA organization design improvement to align with the corporate quality strategy, achieve desired results improvement, sustain quality system gains, and meet emerging business needs.
- Develop capability for cross functional problem solving of plant quality issues, defining root cause and effective corrective actions.
What you bring to the table:
- Bachelor's degree in Technical Field (Chemistry, Engineering, Quality). Master degree is a plus.
- Knowledgeable in all aspects of Quality Assurance with 7-10 years of Quality Assurance experience in an operating plant producing OTC and/or Medical Devices.
- Experienced in laboratory systems and management including microbial lab management and good practices.
- Knowledgeable of FDA regulations for OTC and Medical Products with firsthand experience leading unannounced FDA audits.
- Knowledgeable in ISO Standards: 13485:2016 and 9001:2015
- Demonstrated experience and track record of success in leadership roles, organization culture development, and successful career development of other managers and company associates.
- Knowledge of chemistry with an ability to guide improvement in testing methods, equipment, transformation processes, and on-going improvement in product quality.
- Advanced personal computer skills including word processing, spreadsheets, and databases are required. Additional skills with main applications such as Master Control, PeopleSoft with an ability to guide common practices across the company.
- Capability to communicate ideas and ability to train others effectively using technology and software.