Director of Quality Operations

1 day ago

San Diego, California, United States TriLink BioTechnologies, part of Maravai LifeSciences Full time
Director, Quality Operations

Maravai LifeSciences is seeking a highly skilled Director, Quality Operations to join our team at TriLink BioTechnologies. This role is responsible for managing all aspects of the company's CGMP Quality Operations, including leading teams to address Quality Events, customer communications, metric reporting, and product release.

Key Responsibilities:
  • Develops and implements the quality strategy throughout the organization.
  • Helps create a quality focus culture through collaboration, training, metrics, and risk-based thinking.
  • Manages the company's Quality Operations to support product release, including raw materials and finished goods.
  • Manages all Quality Operations activities, including batch record review and approval, final product disposition, and approval of Quality Events.
  • Works with commercial sales and marketing on customer-facing communications, as well as product managers, and supply chain to ensure quality/regulatory requirements are aligned in Quality Agreements and Supply Agreements.
  • Must be able to interact with Operations Leaders on a daily basis and achieve shared goals with them.
  • Oversees the Management of Change (MOC) process, including quality review and approval, customer notification, and customer approvals, where applicable.
  • Develops strategic programs to advance the Quality Culture, employee retention, and continual improvement.
  • Implements the use of quality tools, such as 5-Whys, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
  • Supports internal and external quality audits (e.g. customers, ISO, etc.).
  • Manages the compilation, review, and trending of quality system metrics for Quality Review Board, Management Review Board, and operational metric reporting.
  • Establishes sustainable and robust processes for phase-appropriate CGMP production and technology transfer of products through these phases, both internal and external.
  • Supervises subordinate employees, including training, employee development, and performance management.
  • Assures compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
Requirements:
  • BS Degree in a scientific discipline with advanced degrees or certifications highly desired.
  • Quality or Operations professional with a minimum of 10 years of experience in a life science industry.
  • Minimum of 5 years of leadership experience.
  • Requires knowledge of cGMPs regulations (21 CFR 210,211 and/or 21 CFR 820), ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients (API), and ISO 9001 and/or ISO 13485 regulations.
  • Must have prior leadership experience in a GMP manufacturing environment.
  • Familiar with cleanroom operations (e.g. operating in a cleanroom, EM monitoring, validation, etc.).
  • Strong and effective verbal and written communication 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 regulatory inspections.

TriLink BioTechnologies offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan. We are an Equal Opportunity/Affirmative Action employer and welcome applications from qualified candidates 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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