Director of Quality and Regulatory Affairs at Sandpoint

Unicep Packaging, LLC, is a privately held contract manufacturing facility located in beautiful Sandpoint, Idaho. Unicep is a world class provider of contract mixing, packaging and private label solutions to the oral health care, pharmaceutical, IVD, cosmetic and nutritional markets for liquids, gels, and semi-solids. We contract fill bottles and our unique, unit-dose, modified blow-fill-seal MicroDose and Twist-Tip vials with a variety of products.

We are currently recruiting for the position of: Director of Quality and Regulatory Affairs

The Director of Quality and Regulatory Affairs is a senior management position and will be responsible for establishing, implementing and assuring quality and regulatory controls in our contract manufacturing facility. The Director provides expertise and guidance in interpreting governmental regulations and internal policies to assure compliance. The Director partners with all departments to establish and drive Uniceps quality system and company strategies.

ESSENTIAL RESPONSIBILITIES:

• Responsible for all regulatory compliance programs for the company. 
• Develop, implement & maintain the Quality Management System to ensure compliance with FDA & other regulatory requirements. Conduct management reviews of QMS.
• Direct the internal audit process, including the oversight of GMP audits of the production facility on a regularly scheduled basis, & as necessary.
• Primary contact for all external audits, including FDA, ISO 9000 & customer audits.
• Review customer & regulatory requirements to ensure company compliance & to stay abreast of new or updated regulations.
• Primary FDA contact, including completing the annual FDA registration updates & keeping Drug & Device listings current.
• Consult in reviews of nonconformances to ensure trends or systemic issues are identified & addressed.
• Audit records of finished products for compliance with manufacturing procedures & GMPs to ensure quality & regulatory compliance.
• Analyze audit data & prepare reports for management review & continuous improvement initiatives.
• Perform external quality audits on suppliers to ensure compliance with product specification.
• Oversee the maintenance of quality system records for facility and all Change Control activities to ensure compliance.
• Review all release documents to ensure compliance with Standard Operating Procedures (SOP).
• Support company growth initiatives by working with other departments (i.e., Program Management, R&D, Engineering, Operations) to ensure new products, processes, & plans are delivered within established time frames & guidelines.
• Establish, prepare, implement, revise, & maintain policies & procedures related to Quality.
• Provide employee leadership through effective communications, coaching, training, & development. 
• Oversee Corrective and Preventive Action program
• Oversee quality control laboratories
• Oversee all validation activities
• Provide regulatory guidance for new product introduction including labeling review, development of specifications, and risk management

MINIMUM REQUIREMENTS:

• Bachelors degree in Chemistry, Engineering, or a related field, or a combination of equivalent education and experience.
• Minimum 10 years experience providing GMP regulatory compliance in Manufacturing or Quality Assurance.
• Minimum 5 years experience in an FDA manufacturing facility.
• Detailed knowledge of GMP, ISO 9000, & FDA requirements.
• Proven experience implementing quality systems in a GMP environment.
• Auditing certification preferred.
• Excellent analytical & problem solving skills. 
• Prior supervisory experience.
• Demonstrated leadership skills & ability to get results through others.
• Good communication & interpersonal skills.
• Demonstrated project management experience.
• Proficient with Microsoft Office (Word, Excel, Project).
• Ability to manage multiple projects & prioritize to meet established timelines.

EOE/Drug Free Workplace  
Country: USA, State: Idaho, City: Sandpoint, Company: Unicep.