SENIOR MANAGER,

QUALITY AND OPERATIONAL SYSTEMS (#119)

Summary

Invenra is seeking a highly motivated and experienced Sr. Manager, Quality and Operational Systems to help deploy a Quality Management System (QMS) and other Operational systems tailored to the specific demands of our market.  The company is engaged in developing internal and collaborator drug assets from R&D through preclinical.

 

The role will include working collaboratively with various internal functional groups and external consultants to implement and improve Operational systems such as Quality, OSHA/EPA compliance, and Equipment Maintenance and Calibration. This role will also participate as the Quality representative on asset development project teams. The position requires strong interpersonal, communication and organizational skills, attention to detail, and a passion to build/implement new processes and programs.   

 

Ideal candidates are currently employed or have been employed in similar types of positions and want to be a part of an expanding biotech company doing innovative work. Candidates must bring intellectual, professional and personal values that complement the founding team: the highest standard of integrity, a tremendous work ethic and a passion to succeed.

 

Essential Job Responsibilities

  • Working collaboratively to generate, maintain, and improve the QMS infrastructure

  • Leading the development and implementation of OSHA/EPA programs with internal employees and consultants

  • Helping to establish an equipment calibration and maintenance program with the Lab Management team 

  • Writing procedures and policies

  • Observing and assisting other groups in the generation of scalable processes and SOPs

  • Managing the document control/change process

  • Reviewing notebooks/batch records related to shipments to CROs and collaborators

  • Team member participating in the design, development, and execution of projects to help assure requirements will be met to support an IND filing

Knowledge, Skills and Abilities

  • Experience generating SOPs and other types of controlled documents

  • Experience auditing internal and/or external quality systems

  • Experience with the development and/or transfer of products or technology

  • Great interpersonal, communication, and listening skills

  • Attention to detail

  • Proven problem-solving skills

  • Reliable and have a positive and professional attitude

  • Enjoy and embrace working in a fast-paced environment

  • Experience on a safety committee or building out a OSHA/EPA compliant program is preferred

  • Experience in an ISO 9001 or ISO 13485 environment is preferred

  • Experience in an early-stage drug discovery and development organization is preferred

  • Experience in a company with protein/antibody manufacturing is a plus

  • Certified Quality Auditor and/or Quality Engineer is a plus

  • Process Validation experience is a plus

 

Education

The successful candidate will have a Bachelor or Master’s degree in biological sciences, biochemistry, etc. Greater than 10 years of industry experience (preferably in biotechnology or pharma), with at least 5+ years in a Quality role or collaborating with Quality to design and document processes for their functional area.

 

Invenra

Invenra is a rapidly growing biotechnology company developing novel technologies for multispecific antibody drug discovery.

 

This position comes with a competitive compensation and benefits package, including health and dental benefits, 401k match, stock option grants, paid time off, tuition reimbursement and paid company holidays. At Invenra, we believe in maintaining the highest ethical standards and ensuring that all employees have a good work-life balance.

 

Resumes should be sent to hr@invenra.com

Invenra®

505 South Rosa Road; Suite 235, Madison, WI 53719       info@invenra.com  |   608.441.8319

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