Our Director/Manager, Quality will report to the Vice President, Technical and serves as a leader within the Quality Department ensuring Systems are robust, appropriate, and followed throughout the manufacturing environment in order to guarantee quality products and processes that meet regulatory and customer requirements and are appropriate to the product categories. This position participates in audits of Autumn Harp by external regulatory agencies and customers and understands regulatory and customer requirements for the industry. Additionally, works extensively and collaboratively with other department heads on improvement projects.
- Oversee and closely review Quality Systems to ensure programs are comprehensive, streamlined, achievable, and being followed.
- Ensure quality documented procedures and policies reflect work practices and vice versa.
- Leader within the Quality Department, lead Quality Control and Assurance teams, work closely with Quality Engineers to ensure consistency in processes and policies as new requirements are put into place.
- Participate in developing Quality staff by recruiting, managing, developing, and training employees.
- Work closely with Operations Management and teams to understand proposed facilities and equipment upgrades. Determine any quality critical issues, documentation needs, etc. Work through issues with group until complete.
- Participate fully in on-site audits by regulatory agencies, customers, and 3rd parties to ensure questions and requests are addressed by current Systems. Work with internal teams to address issues as required, making sure all new processes fit within Systems.
- Conduct and document risk assessments and investigations related to the Quality Systems.
- Collaborate with other departments on issues related to Quality Systems, overall quality and manufacturing improvements.
- Contribute to preparing yearly Quality budget, tracking spending, and analyzing and addressing variances.
- Participate in establishing and reporting department metrics.
Essential Job Requirements:
- Experience in an FDA and/or ISO environment
- Highly organized and detail oriented
- Ability to manage, prioritize, and delegate numerous projects
- Experience with global regulatory issues, raw materials, and product specifications
- Must be solution-oriented with initiative and strong problem solving skills
- Excellent communication skills: written and verbal/computer proficiency in Work and Excel
- Team Player with strong interpersonal skills
- Strategic thinker with capability and willingness to dive into details and implement processes
- Strong Project Management skills
Job Type: Full-time
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
- cGMP: 5 years (Preferred)
Work Location: One location