Senior Quality Manager

BIOLYPH; Chaska (MN); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k

Paid time off

Life insurance

EAP (Employee Assistance Program)

Company events

Job summary

BIOLYPH, based in Chaska, MN, is seeking a Senior Quality Manager to lead the Quality Department and own the Quality Management System. This full-time role offers a 4- or 5-day work week, competitive benefits, and strong life–work balance.

You will set the strategic vision for quality, supervise staff, coordinate cross‑functional initiatives, and ensure ISO 13485 and FDA/cGMP compliance across the organization.

Qualifications

• Bachelor's degree in Life Sciences or Chemistry.
• Five+ years in a Quality Leader role.
• Quality Assurance in FDA-regulated environments.
• GMP/GDP experience.
• ISO 13485 experience preferred.
• Quality certifications preferred.

Responsibilities

• Maintain a QMS aligned with ISO 13485 and 21 CFR Part 820 through documentation and training.
• Lead the Quality Department, hire and manage staff, and report to Executive Management.
• Develop and communicate quality objectives aligned with BIOLYPH policies.
• Perform management reviews and monitor QMS deliverables.
• direct supplier audits and quality investigations.

Skills

Quality leadership

QMS

Regulatory compliance

GMP/GDP

ISO 13485

Continuous improvement

Documentation control

Education

Life Sciences degree

CQIA/CMQ/CQE

Job description

Salary Range: $125,000.00 To $150,000.00 Annually

BIOLYPH is growing! We are seeking an experienced, team-oriented, and responsive Senior Quality 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 Senior Quality Manager is BIOLYPH's appointed management representative of the Quality System. This role is primarily responsible for developing the strategic vision for the entire Quality department, representing the vision to Executive Management, hiring and leading the department employees, and establishing and monitoring policies and procedures at all levels. In addition, they are fully responsible for the health of BIOLYPH's QMS and work cross-functionally to meet or exceed BIOLYPH's and our Clients' needs and expectations.

Essential Functions:

• Quality System Representative:
  • Maintain a Quality Management System (QMS) that models the intent of ISO 13485 and cGMP (21 CFR Part 820) through documentation, training, and implementation
  • Identify opportunities to proactively assure compliance to applicable internal, domestic, and international quality regulations
  • Formulate, maintain, and communicate quality objectives complementary to BIOLYPH's policies and goals
  • Report QMS status, lead Management Review meetings, and monitor QMS-related deliverables
  • Review and disposition QMS modifications
  • Participate in Continuous Improvement activities
  • Demonstrates effective Change Leadership
• Management:
  • Coordinate across functional areas, business units, and/or geographies to achieve company or area goals
  • Identify and manage activities related to adding value to the organization through risk reduction and cost improvement
  • Evaluate and elevate the need for additional team resources
  • Accomplish department objectives by managing staff, planning, and evaluating department activities
  • Complete and deliver Employee Performance Assessments
• Quality Systems:
  • Facilitate document control and document retention activities
  • Review and disposition change controls, deviations, corrective actions, Client complaints, procedure updates, and other Quality System documentation
  • Direct the development and implementation of job-specific training tools across the organization
  • Manage and direct Supplier Management program, including conducting quality audits and generating audit reports
• Production Support:
  • Champion BIOLYPH's goal of Perfect Finished Parts
  • Assist with daily production quality questions/issues
  • Serve as the point of escalation/contact as business needs dictate
• Client Support:
  • Establish and maintain relationships with Client Quality Representatives

Secondary Job Functions:

• Support the Production Team as needed
• Perform miscellaneous duties and projects as required

Qualifications:

• Bachelor's Degree in Life Sciences or Chemistry
• Five plus years of experience in a demonstrated Quality Leader role
• Quality Assurance experience in an FDA-regulated manufacturing or other technical environments
• GMP/GDP experience
• Experience building and maintaining Quality Management Systems (preferred)
• ISO 13485 experience (preferred)
• Quality certification, CQIA, CMQ, or CQE (preferred)

Other Requirements:

• Organized with close attention to details
• Advanced written and oral communication
• Time management and prioritization skills
• Capable of applying Quality Tools to diverse situations
• Performance management
• Project Management
• Data analysis skills
• Capable of working independently and as a team
• 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. 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