Senior Quality Manager

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

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