Job Description
The Role:
The Quality Manager will ensure that the site meets GMP, compliance and regulatory standards. You will maintain the site in compliance with IS0 9001 standard are manufactured under GMP regulations and all shipped pharma products are of good quality.
How You Will Make an Impact:
- Ensure EHS compliance and continuous improvement in EHS performance
- Ensure department goals and KPIs are aligned with site objectives
- Develop budget plans following a zero-based approach and manage Quality costs
- Provide site strategy for quality management
- Be the Management Representative for obtaining and maintaining quality certifications (ISO 9001 etc.)
- Oversee execution of raw material and finished good testing and COA generation
- Provide site strategy and procedures for maintenance of analytical data and document control
- Provide strategy for in-process quality control
- Oversee laboratory, analytical equipment and facilities
- Review customer specifications and ensure that processes are capable
- Analyze and lead improvement efforts related to process capabilities (CpK) of production processes to eliminate product defects
- Focal point for site customer complaint investigation and response processes
- Ensure EHS compliance and continuous improvement in EHS performance
- Assure a compliant quality operation (incl. e.g. Responsible Care, ISO 9001/14001)
- Manage QA aspects of the site MOC process for pharma and non-pharma operations.
- Create and improve customer engagement touchpoints for matters related to product quality and regulatory compliance
- Assess and evaluate supplier quality processes to ensure alignment with SI quality standards; apply corrective action accordingly
- Oversee audit and investigation processes related to quality and for corrective measures to achieve and maintain compliance
- Evaluate and improve quality process work plans to reduce product rejection rates
- Assure the operation, maintaining, and improvements of the site's GMP and MOC processes
- Maintain FDA export certifications for regulatory bodies world-wide (US, Canada, EU, Mexico, Brazil, Japan) when applicable
- Active participation in any regional QA associated initiatives (internal/external)
- Serve as member of Site Leadership Team
- Work with other functional leaders to identify and solve problems to support achievement of site goals
- Anticipate future requirements for site and develop strategic plans to meet them
Creating Extraordinary Starts With:
- Bachelor's degree in Chemistry or Chemical Engineering, or other STEM discipline
- Minimum of ten years' experience in process industry manufacturing
- Minimum of five years Supervisory experience
- Deep level of chemistry knowledge with training in analytical chemistry and experience in raw material and finished good testing, in-process quality control, Quality Certification Management, quality auditing quality statistics
- ISO 9001, 1400, RC1400 knowledge certification; ISO Auditor; cGMP certifications preferred
What We Value:
We strive for all employees to nurture physical, mental and emotional health both personally and professionally. Our commitment to health and wellness centers around prevention, early detection and embracing a healthy lifestyle. Some offerings may vary by role or region, but may include:
- Physical Health benefits including competitive Medical, Dental, and Vision packages, company contribution to Health Savings Account, cash incentive for Annual Physical and reimbursement
- Financial Wellness opportunities including company paid life insurance and disability plans, 401(k) Retirement Plan with generous company match, and certified Financial Planning & Investment services
- Mental Health benefits including generous Paid Time Off and 10 Paid Holidays, Paid Parental Bonding Leave, and much more!
Essential Solutions with Extraordinary Results
SI Group is a global leader in the innovative technology of performance additives, process solutions, active pharmaceutical ingredients, and chemical intermediates. Our solutions are essential to many diverse industries and applications, creating extraordinary results. We drive value by enhancing the quality, performance, and durability of countless items we use every day.
We are on a journey to captivate our customers at every level. Whether that means expanding our capabilities, global reach, or providing new innovations and technologies that create value. Our approach is customized to exceed customer needs and deliver superior performance.
