Senior 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 Senior Manager QA Operations . The Senior Manager QA Operations is responsible for leading all aspects of the quality operations function including product release raw material release and approval of quality events (e.g. deviations nonconformances etc.). This role serves as the senior Quality point of contact for internal and external customers and leads the team priorities and resources required to support compliant and timely QA activities. The position ensures compliance with company policies and procedures and applicable domestic and international standards and regulations.

How you will make an impact:

• Lead the quality operations team for approval and release of finished good products (e.g. critical raw material for further processing Drug Substances/APIs) as needed.
• Approve master and executed batch records including final product disposition. Review and approve OOS deviations and nonconformances prior to product release.
• Conduct quality investigations to assess root cause corrections corrective actions preventive actions and effectiveness. Use of quality tools such as 5-Whys FMEAs DMAIC Cause and Effect Diagrams Process Mapping etc.
• Review and approve quality agreements custom product project orders and other customer contracts containing quality related information.
• Be the quality point of contact for internal and external customers.
• Lead cross-functional teams in risk identification and mitigation activities during risk management process.
• Lead and/or support external quality audits (e.g. customers ISO etc.).
• Develop maintain and communicate quality metrics to ensure visibility of QMS health.
• Work with various functions including Manufacturing QC R&D commercial customer service technical support facilities IT etc. to develop implement and continuously improve the Quality Management System.
• Manage subordinate employees including training employee development and performance management.
• Perform other functions and duties as required

The skills and experience that you will bring:

• Minimum Bachelors Degree in scientific discipline (Chemistry Biology Bioengineering etc.).
• Quality professional with a minimum of 10 years relevant experience in a life science industry.
• Minimum of 5 years of leadership experience.
• Requires knowledge of ISO 9001 (or ISO 13485) standards and cGMPs regulations (e.g. 21 CFR 210 211 or 21 CFR 820 ICH Q7).
• Familiar with cleanroom operations (e.g. operating in a cleanroom EM monitoring validation etc.)
• Understand Quality Event processes (deviation non-conformance OOS CAPA etc.)
• Strong and effective verbal and written communication skills.
• Strong interpersonal teamwork and customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
• Experience in supporting inspection readiness activities resulting in successful inspections.

#LI-Onsite

The benefits of being a #Mirac le Maker:

• You have the potential to change improve and save lives around the world.
• You have the opportunity to be a part o wner in Maravai through RSU grants and optional employee stock purchase plans .
• We offer comprehensive medical plans and H SA /FSA options .
• Fertility & family planning assistance .
• A variety of additional optional benefit s 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 our Benefits & 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.

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 .

Required Experience:

Senior Manager