Job Title: Quality Excellence Manager
Location: Swiftwater, PA
Main Responsibilities- Promoting a culture of excellence and ensuring full implementation and sustainability of SMS 2.0
- Identifying and implementing continuous improvement initiatives to enhance product quality and operational efficiency, in line with SMS 2.0 methodology
- Monitoring and analyzing quality performance data to identify trends and areas for improvement
- Supporting the investigational process of complex events to ensure the identification of the true root cause and relevant CAPA
- Developing a culture of continuous improvement within the site
- Developing initiatives for staff and management team to foster the capacity to identify and implement quality improvements
- Developing and maintaining quality metrics and performance indicators
- Conducting regular assessments of quality processes and facilities
- Implementing in quality department global quality initiatives related to operational excellence
- Managing the quality excellence team and ensuring their proper qualification for their activities
- Actively contributing to global networking and initiatives
- Primarily on-site office-based with supportive presence on the manufacturing floor and ability to gown for Gembas.
Key Involvement In Decision Making ProcessKey Roles (D,A,I)- Decide on continuous improvement strategy and roadmap (D)
- Advise on quality improvements and initiatives (A)
- Advise on data-driven quality improvements (A)
- Establish quality metrics in line with global quality (D)
- Decide on initiatives to promote a culture of continuous improvement (D)
- Advise on the development of quality performance metrics and reporting systems (A)
About YouBasic Qualifications- Bachelor's degree in science, Engineering, or a related technical field; master's degree preferred
- 5+ years of experience in Quality Assurance roles, with a strong understanding of pharmaceutical manufacturing processes and regulatory requirements
- 5+ years of experience in manufacturing or Operational Excellence, within the pharmaceutical, biotechnology, medical device, or another closely related regulated industry.
Technical Skills- Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality processes
- Proficiency in Excel and Power BI to build dashboards and visualize insights
- Leadership skills to guide cross-functional teams, manage projects, and drive quality initiatives
- In-depth understanding of regulatory requirements and GMP in the pharmaceutical industry
- Strong presentation skills, with the ability to communicate data-driven insights clearly to cross-functional teams and leadership
Soft Skills- Strong communication and interpersonal skills, with the ability to influence without direct authority
- Strong time management and prioritization in a fast-paced, cross-functional environment
- Proactive, solution-oriented mindset, with the ability to anticipate risks and define clear action plans
The salary range for this position is:
$113.250,00 - $163.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
