Job Duties and Responsibilities
1. Develop, maintain, and manage a lean, world-class quality system that gives the client a competitive advantage in manufacturing and regulatory compliance.
2. • offer leadership to constantly power improvement of all elements of the first-rate device required to help contemporary GMP's and production procedures.
3. • increase a strong exceptional gadget that builds high-quality and "mistakes proofing" into all procedures.
4. • increase distinctly predictive metrics and KPI's to make certain that proper decisions are made.
5. • gives guidance and interpretation on regulatory topics relevant to our commercial enterprise (e.G. FDA, CFR, USP) to help us lessen risk to our purchaser and to the corporation.
6. • Lead control reviews that force continuous development.
7. • ensure that employee education is compliant with regulatory necessities and patron expectations.
2. Manage QA functions for the Complex Value Stream manufacturing site, assuring a high degree of product quality and regulatory compliance for the value stream.
- Provide leadership to drive continuous improvement of product quality and compliance.
- Ensure that quality events are thoroughly and quickly investigated, driving to true root cause and effective CAPA solutions that permanently solve problems.
- Ensure that Complex Value Stream quality processes are aligned with principles of the client's Lean Business System.
3. Develop, maintain, and manage a Facility Audit program that assures compliance and drives continuous improvement of processes, process compliance, and product quality.
- Develop and manage audit processes that drive continuous improvement: internal, external and third party.
- Develop criteria that will assure a state of constant readiness in the plant when followed.
- Ensure timely execution of facility audits and provide the feedback needed to ensure readiness.
- Ensure that customer audits build customer trust and meet customer expectations.
4. Validation – Ensure process, cleaning and equipment protocols/reports met our customer requirements, ensure FDA compliance, and produce quality products.
- Manage and maintain Validation Master Plans that provide a high degree of compliance assurance and meet customer expectations.
- Review and approve IQ, OQ, and PQ protocols on equipment, processes, and cleaning.
- Review and approve IQ, OQ, and PQ reports.
5. Management Competencies - develops and maintains an organization of high performing people who are aligned with the client's Vision, Purpose, and Values.
- Selection - finds and retains the right people in each position and selects the right candidates.
- Training - provides employees the skill and information they need to perform their jobs successfully and follows through to ensure learning.
- Management / Leadership - coaches employees to succeed and develops them for the future.
- Correction / Redirection - addresses chronic unacceptable performance in a way that causes improvement.
- Performance Evaluation - objectively values and defines performance against outcomes and standards.
- Employee Development - follows a plan to develop performance and prepare people in their career development.
- Termination - knows how to document employee performance and construct a case leading to correct termination decisions.
6. Understand and maintain a culture of “lean action” within the department so that the team lives lean better than any other organization.
- Implement and maintain standards and processes that eliminate waste throughout the department.
- Apply and utilize "lean tools" to permanently implement improvements.
- Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)
7. Perform other work as assigned.
- Bachelor's Degreerequired with a preferred major in Chemistry, Microbiology, Pharmaceutical Science or other science fields
- 10+ years of experience in a Quality Assurance position in an effective Lean manufacturing environment within the pharmaceutical industry
- 5+ years of experience in a Quality Assurance Manager role
- Lean or Six Sigma Certifications preferred
- ASQ Certification would be a plus
Job Type: Full-time
- Quality Assurance: 10 years
- Quality Assurance Manager: 5 years
- Pharmaceutical Manufacturing: 5 years
- Site Compliance: 5 years
Required licenses or certifications:
- ASQ Certified Quality Auditor
- LeanSix Sigma Green Belt
- Lean Manufacturing
- ASQ Certified Quality Engineer