Quality Systems Manager

BIOLYPH is seeking an experienced, team-oriented, and responsive Quality Systems Manager. This full-time position offers your choice of a 4 or 5 day work week, competitive benefits, growth opportunities, and a culture of life-work balance.

The Quality Systems Manager is primarily responsible for developing, implementing, and monitoring the required sub-systems of BIOLYPH’s Quality Management System (QMS). In doing this, they serve as the back-up Quality System Representative and help monitor the health of the QMS. This will be done in alignment with BIOLYPH’s business model of producing our Clients’ IVD/RUO products Effectively, Efficiently, and Economically.

Essential Functions:

• Quality Management System:
  • Implement and maintain all necessary systems and procedures to satisfy applicable regulations and/or expressed Client needs
  • Analyze quality data and provide insights for decision-making and continuous improvement projects
  • Work closely with cross-functional teams to ensure the alignment of quality objectives with overall business goals
  • Review and disposition change controls, corrective actions, procedure updates, equipment schedule determinations, equipment monitoring logs, and other Quality System documentation
  • Perform risk assessments and ensure appropriate controls are in place to prevent hazards
  • Facilitate systemic projects to include those originating from corrective action plans.
  • Maintain up-to-date knowledge of regulatory changes and ensure timely updates to the QMS
• Validation System:
  • Manage and monitor the validation system
• Supplier Management System:
  • Manage and monitor the Supplier Management system
  • When required, perform Supplier Audits
• Audit System:
  • Plan and execute Internal Audits. Facilitate Client, Third Party, and prospective Client Quality Audits
  • Ensure completion of Client Quality Surveys/Questionnaires
• Continuous Improvement:
  • Identify and/or participate in Continuous Improvement activities

Secondary Job Functions:

• Identify and manage activities related to adding value to the organization through risk reduction and/or cost improvement
• Support the Production Team as needed
• Perform miscellaneous duties and projects as required

Qualifications:

• Required Qualifications: Bachelor's Degree in Life Sciences, Chemistry or related field
• Five plus years of experience in a quality leadership role, with demonstrated success in managing Quality Systems. Experience working in an FDA-regulated manufacturing environment or other technical, highly regulated environments. Strong knowledge of GMP/GDP standards and practices. Proven ability to build and maintain effective Quality Management Systems
• Preferred Qualifications:
  • ISO 13485 experience and familiarity with global medical device quality standards
  • Certifications such as CMDA, CQA, CQIA, CMQ, or CQE.
  • ISO 13485 Lead Auditor or ISO 13485 Internal Auditor certification.

Other Requirements:

• Strong communication, organizational, and leadership skills
• Ability to work effectively with teams and individuals at all levels
• Detail-oriented with a problem-solving mindset
• Proficient in quality software tools and documentation systems
• Well organized
• Interpersonal, negotiation, time management, and prioritization skills
• Knowledge of data analysis techniques
• Presentation skills
• Must be able to wear appropriate PPE
• Ability to sit for extended periods of time
• Normal vision acuity (with or without corrective lenses)
• Ability to identify and distinguish colors
• Ability to lift 10 lbs routinely/often/occasionally
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 25 lbs occasionally

About BIOLYPH:

Established in 1993, BIOLYPH is a dynamic, World-Class Contract Lyophilization and Component Packaging Service Company located in Chaska, Minnesota. Facilitated by the win-win relationships created with our Clients, we have continually experienced year-over-year growth. With the support of Management, BIOLYPH has maintained a workforce that is collaborative and innovative.

BIOLYPH Offers:

• Competitive pay commensurate with experience
• Benefits for full-time employees include:
  • Health, Dental, Vision, Life, Short-term, and Long-term disability insurance
  • Paid Time Off, Paid Holidays including Floating Holidays, Paid Birthdays
  • 401k
  • Employee Assistance Program
• Frequent company-sponsored events
• Clean, friendly, and collaborative work environment