Manager, QA Operations

Who we are:

Maravai LifeSciences translates extraordinary science into everyday miracles helping biotech biopharma and life sciences companies everywhere deliver novel vaccines therapeutics and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the worlds leading biopharma vaccine diagnostics and cell and gene therapy companies.

At Maravai we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work we cultivate an environment in which we can lead together providing differentiated value to our customers and enabling the miracles of science. For over 35 years Maravais portfolio companies have served as a catalyst for innovative lifesaving technology for humanity. Pioneering nucleotide research since its inception we are now leading the way in the rapidly expanding mRNA market.

Your next role as a Miracle Maker

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Manager QA Operations. The Manager QA Operationsis responsible for the implementation of policies and procedures to ensure adherence to production quality standards and oversight of the Companys electronic ISO 13485:2016 Quality Management System. The Quality Assurance Manager is expected to ensure compliance with operational statutory and regulatory requirements in support of the Companys business objectives.

How you will make an impact:

• Manage Quality Assurance department day to day operations including implementing training and performance management activities for direct reports
• Implement and periodically evaluate documentation and policies to ensure continuous compliancetothe quality integrity and efficiency standards set by the organization the ISO 13485:2016 standard and other statutory and regulatory requirements.
• Collaborate with management toidentifyand fill documentation and process gapsto maintain QMS compliance and address CAPAs NCs and audit findings
• Author andmaintainquality documentation overseetimelyreviews of all work instructions associated with production and quality control activities
• Support Quality Control with customer complaints and Out of Specification (OOS) investigations
• Activelyparticipateon core teams and provide deliverables from QA on quality processes anddocumentation practices from production through testing and shipment
• Implement and track metrics tomonitorperformance associated with Quality management
• Identifyand implement efficiency improvement initiatives in support of Continuous Improvement
• Facilitate proactive solutions by collecting and analyzing quality data
• Manage Internal Audit Program
• Perform other functions and duties as

The skills and experience that you will bring:

• Bachelors Degree in Life Science Biology Chemistry or Pharmaceutical or related discipline
• 3-5 years of managerial experience in non-academic biotechnology related industry
• 1-3 years of supervisory experience
• Proven experience with: ISO 13485 certification federal regulations 21 CFR 820 and 21 CFR Part 11
• Industry experience in a Good Manufacturing Practice (GMP) environment is preferred
• Thorough knowledge of analytical testing industry standards and quality assurance methodologies
• Excellent communication and presentation skills are
• Demonstrated scientific problem solving skills translated into consultative selling process where the win is for both the client and the company
• Ability toparticipatewith others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project andmaintainstrong relationships within all parts of company
• Proven ability to thrive in a start-up/change oriented environment
• Great attention to detail and results driven approach
• Self-starter with ability to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
• Proven coaching mentoring teambuildingand leadership skills

#LI-Onsite

The benefits of being a #MiracleMaker:

• You have the potential to change improve and save lives around the world.
• You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
• We offer comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options including pet insurance.
• Retirement contributions.
• Holidays & Paid Time Off.

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at ourBenefits & growth site at view more opportunities to become a #MiracleMaker visit our career site at a Maravai LifeSciences company is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex including sexual orientation and gender identity national origin disability protected Veteran Status or any other characteristic protected by applicable federal state or local law.

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HIRING SCAM ALERT

Recently individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists please be aware that:

• Maravai LifeSciences will never interview a candidate over RingCentral similar messaging apps or social media (e.g. Telegram Google Hangouts WhatsApp Facebook Messenger etc.)

• Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.

If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences please reach out to us directly at . If you believe you have been a victim of fraud you can report this activity at: or .