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 world's 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 equitableculture 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, Maravai’s 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/API's) 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-Why's, FMEA's, 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, Bachelor's 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 #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 our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/
To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/
Maravai LifeSciences 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 [email protected]. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov.
Skills Required
- Bachelor's degree in a scientific discipline such as Chemistry, Biology, or Bioengineering
- At least 10 years of relevant experience in a life sciences industry
- At least 5 years of leadership experience
- Knowledge of ISO 9001 or ISO 13485 standards
- Knowledge of cGMP regulations, including 21 CFR 210, 21 CFR 211, 21 CFR 820, or ICH Q7
- Familiarity with cleanroom operations, environmental monitoring, and validation
- Understanding of quality event processes, including deviations, nonconformances, OOS, and CAPA
- Strong verbal and written communication skills
- Strong interpersonal, teamwork, and customer-interfacing skills
- Strong problem-solving and analytical investigation skills
- Ability to organize, prioritize, and manage multiple tasks
- Experience identifying and resolving quality issues and discrepancies
- Experience supporting inspection readiness activities resulting in successful inspections
What We Do
Maravai brands set the standard in nucleic acid products and services, enzyme development, and biologics safety testing. From producing revolutionary mRNA technologies that drive infectious disease vaccines, cancer vaccines, and other cell and gene therapies to delivering gold-standard bioprocess impurity detection solutions, Maravai is helping life sciences companies overcome their biggest development and manufacturing challenges to streamline and scale from research through clinical trials to commercialization. For over 35 years, Maravai’s brands have served as proven catalysts for innovative, lifesaving technology for humanity. Across our portfolio of brands, we hold numerous patents and offer more than 1,500 innovative products and services, including CleanCap® technology, CleanAmp® hot start PCR, Antibody Affinity Extraction™, EndonucleaseGTP®, PROTEIN A MIX-N-GO™, MockV®, Sterling™, Glen Pak™, Glen Gel-Pak™. Each of our brands are ISO-9001:2015 certified and have earned hundreds of thousands of citations in peer-reviewed scientific publications.
