The Director of Quality Systems and Compliance will be tasked with leading the Quality Systems,and Quality Assurance program at Denison.

• Provide quality assurance leadership, direction and support of corrective action/preventive actions. Support the development and on-going generation of quality metrics.
• Review non-standard issues and develops action plans to rectify situation accordingly.
• Maintain quality systems in support of regulatory and customer requirements.
• Manage the quality assurance incoming inspection process for components according to the company and customer specifications, procedures as well as external standards.
• Manage the batch record process including final quality assurance review and release of finished goods.
• Act as quality and regulatory advisor to President and other executives.
• Manage the documentation change control process including SOP’s and internal specifications.
• Reviews, analyzes and develops rationale for recommendations to policy changes to align to business needs.
• Effectively manage department resources, negotiate deliverables and meet commitments.
• Provide leadership, coaching and mentoring to assure a competent, efficient and effective QA organization that works well in cross functional teams. Assure staff is always current with all required training.
• Lead all continuous improvement activities for both product and processes.

Qualifications & Experience

In addition to the above, we would look for the following specific competencies:

• Experience in manufacturing for OTC and/or cosmetic products.
• High proficiency and knowledge of 21 CFR
• Ability to bring knowledge acquired through previous experiences and adapt and implement strategies catered to Denison.
• Experience working with Operations with consolidated goals.
• Experience with Streamlining process to align to business needs.
• Working knowledge of statistical process control tools and methods.
• Highly proficient in use of software and systems including ERP, Access, spreadsheets and other presentation tools.
• Knowledge of the following elements is necessary: inspection and measurement, design control realization, change management, documentation control, validation, project management and regulatory agency (FDA, DEA, ISO, etc.) requirements.
• Track record of accomplishments in quality improvement and successfully satisfying customer (internal or external) expectations.
• Excellent written and oral communication skills that will aid in inspiring team members.
• Capable and comfortable leading training sessions and other formal presentations.
• Good financial acumen and a grasp of income statements, balance sheets, cash flows, and other financial metrics.
• 5-10 years in a pharmaceutical processing environment in a Quality Assurance organization.
• Bachelor’s degree required; MBA is preferred.

Personal Attributes

• Strategic Thinker/Sees Big Picture
• Manages Complexity & Ambiguity/Decisive
• Growth-oriented
• Hands on Management Style
• Continuous Improvement Mindset
• Collaborative
• Customer-centric
• Ability to Hire A-players/Develops People
• Adaptable
• Entrepreneurial Mindset
• Operations oriented