Director of Quality

Director of Quality Corium Innovations Grand Rapids, MI Job Details 6 hours ago Benefits Paid holidays Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications GMP Decision making Manufacturing Cross-functional collaboration Manufacturing company experience Cross-functional communication FDA regulations Senior leadership Full Job Description Corium Innovations is seeking a Director of Quality who will provide the Quality & Compliance direction during Product Development and Commercial Manufacturing for pharmaceutical, OTC, and cosmetic products. This includes collaborating with the project teams and providing direction, expertise, and guidance in interpreting government regulations, agency guidelines and internal policies to assure compliance while driving continuous improvement and using innovative thinking to guide the project teams to build quality into operational processes. This position also defines, implements, and oversees Corium Innovations Quality Management System (QMS) and provides leadership and oversight to Quality Assurance, Quality Systems, Quality, and Quality Control, including hiring, managing, motivating, coaching, and mentoring. Your most Innovative career move is here! At Corium Innovations, we've led the way in innovating drug delivery technologies for millions of patients whose GI systems just can't tolerate pills, who can't remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver, and we need YOU to do it! Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last.

Celebrate Individuals:

We're looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.

Successful Together:

We believe we're better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.

Embrace Innovation:

We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners. Pride in

Ownership:

We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!

Responsibilities:

Oversees the development and maintenance of QA systems, policies, processes, procedures and controls related to QA, CGMP, and Regulatory Compliance to ensure that systems and products conform to established standards and agency guidelines in the interest of lasting customer satisfaction and safety. Develops and drives quality systems and standards and incorporates them into the development and commercial processes using innovative thinking and collaboration with the project team members to help assure that quality is built into the products. Provides leadership, strategic direction, and functional oversight for Corium Quality Assurance and Quality Control departments to ensure requirements are completed through coordination of activities, prioritization, troubleshooting, and communicating information. Directs and provides guidance to all Corium employees in regards to cGMP, Quality Assurance, and Regulatory Compliance. Participates as a core member of the Corium Innovations Operations Leadership Team, which is responsible for oversight of all Corium Innovations site operations. Identifies short- and long-term company and department objectives and plan activities to achieve these objectives. Translate objectives into procedures for use in the Quality System. Makes QA decisions based on knowledge and interpretation of government regulations and guidelines as well as industry standards, risk-based assessments and internal policies to ensure compliance. Participates in FDA, DEA, and ISO Inspections as well as partner audits, including responses to any audit observations resulting from inspections and ensures that all related corrective actions are completed. Participates in industry forums to gain insights in emerging QA/QC practices and applies appropriately to help create ongoing improvements to the development partners. Identifies and monitors quality reporting, trending, and data analysis activities. Leads personnel via training, supervising, performance management, and staff development. Prepares and monitors department budgets.

Qualifications:

BS/MS/ PhD degree in a scientific discipline. 15+ years of pharmaceutical Quality Assurance, Quality Control, and/or Regulatory Compliance experience in a GMP environment, including direct experience interacting with FDA and other regulatory agencies. Minimum 8 years' experience in a leadership role. Possesses thorough knowledge of pharmaceutical/devices, GMPs, FDA regulations and guidance documents and how to use risk-based decision making in applying them to the product development and manufacturing processes. Strategic analytical thinker with strong business acumen. Proven ability to make sound decisions about allocation of resources and managing priorities. Demonstrated team leadership capabilities with a proven track record of meeting objectives. Demonstrated ability to partner with team members, cross-functional leaders, and executive leadership (as necessary) to meet site & corporate objectives Proficient PC skills. Strong project management and interpersonal skills.

Benefits:

Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program. 401(k) retirement savings account with a company match and immediate vesting. 12 paid holidays. Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.