GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
Raleigh-Durham, NC

Director, Manufacturing Quality Operations # 3074 (Raleigh, NC)

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Employer Provided Salary: $107,000-$142,000 Annually
Salary data is provided by the employer. Please note this is not a guarantee of compensation.

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit

This role leads GRAIL's Manufacturing Quality Operations, focusing on enhancing GRAIL's quality management system for manufacturing. It involves global Quality Assurance oversight, team management, and support for IVD, clinical trial, and LDT reagent manufacturing, as well as external specimen collection kit production. The position is an on site role, based at GRAIL’s RTP Durham, North Carolina facility with occasional travel to Menlo Park (Bay Area), CA.

You will:

  • Direct GRAIL’s RTP and Menlo Park Manufacturing Quality Operations (MQO) teams.
  • Ensure compliance with regulatory requirements (21 CFR 820, ISO 13485) at manufacturing and warehouse locations.
  • Lead resolution of product quality issues, including deviations, NCRs, and CAPA workflows.
  • Oversee Quality partnerships for equipment management, validation programs, and warehouse operations.
  • Oversee Quality partnerships for IVD labeling compliance.
  • Partner with Operations to ensure quality of products.
  • Maintain communication on critical quality issues.
  • Develop and execute quality strategies for business objectives.
  • Monitor and report manufacturing quality data.
  • Act as SME during audits/inspections.
  • Ensure Device Master Record/Medical Device File compliance.
  • Establish and implement Acceptance Activities processes including Receiving and Finished Product inspections.
  • Control quality-related budget and costs.
  • Interface with auditors and regulatory bodies.
  • Collaborate with site leadership and support cross-functional projects.
  • Promote a culture of quality and diversity.
  • Lead, develop, and manage staff.

The required background and qualification will include:

  • BS/BA degree + 12 years related experience, or Masters + 10 years, or PhD + 8 years within a medical device, pharmaceutical, or biotech quality management system.
  • Extensive managerial experience with applicable regulations and standards (IVDR, 21 CFR 820, ISO 13485, ISO 14971, 21 CFR 11).Leadership, organizational, and regulatory inspection experience.
  • Excellent verbal and written communication skills.
  • Technical and regulatory comprehension.

The preferred background and qualification will include:

  • Master’s degree or MBA.
  • Next Generation Sequencing (NGS) experience.
  • Clinical laboratory QMS experience (ISO 15189, CLIA,CAP, NYSDOH).

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.

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What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Volunteer in local community
Partners with nonprofits
Intermountain Healthcare
Open door policy
OKR operational model
Team based strategic planning
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
In-person all-hands meetings
Employee awards
Flexible work schedule
Remote work program
Dedicated diversity and inclusion staff
Mandated unconscious bias training
Diversity manifesto
Mean gender pay gap below 10%
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Wellness programs
Access to the apps like CALM, empowerDX, Progyny, Happify, Spring Health, iPrevail, and more
Team workouts
Team workouts and access to ClassPass
Mental health benefits
Number of wellness programs to include:
Abortion travel benefits
Financial & Retirement
401(K) matching
Effective 2023 GRAIL will match up to 3k
Company equity
Performance bonus
Pay transparency
Child Care & Parental Leave Benefits
Childcare benefits
Generous parental leave
Family medical leave
Company sponsored family events
Fertility benefits
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Company-wide vacation
Office Perks
Commuter benefits
Company-sponsored outings
Free daily meals
Free snacks and drinks
Drinks and snacks available
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Onsite gym
Professional Development Benefits
Job training & conferences
Promote from within
Mentorship program
Online course subscriptions available

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