Director, Quality Operations

Maravai LifeSciences enables the development of drug therapies, diagnostics and novel vaccines and supports research on human diseases through its portfolio of market-leading companies and proprietary technologies. Maravai companies are global leaders in providing products and services into 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. TriLink BioTechnologies, a Maravai LifeSciences company, is looking for a Director, Quality Operations to join our growing team! This role is responsible for managing all aspects of the company's CGMP Quality Operations, including leading teams to address Quality Events (e.g. CAPA, nonconformances, deviations, complaints, etc.), customer communications, metric reporting, and product release. This role ensures the development and manufacture of products in compliance with company policies and procedures and applicable domestic and international standards and regulations. A primary requirement for this role is an understanding of Phase appropriate CGMPs and when to apply those throughout product lifecycle development.Responsibilities

Develops and implements the quality strategy throughout the organization. Helps create a quality focus culture through collaboration, training, metrics, and risk-based thinking.Manage the company's Quality Operations to support products release including Raw materials and Finished Goods. Finished goods may be critical starting materials through commercial Active Pharmaceutical Ingredients.Manage all Quality Operations activities, including Batch Record review and approval, final product disposition, and approval of Quality Events (e.g. OOS, deviations and nonconformances) prior to product release.Work 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.Oversee the Management of Change (MOC) process, including quality review and approval, customer notification, and customer approvals, where applicable.Develop strategic programs to advance the Quality Culture, employee retention, and continual improvement.Implement use of quality tools, such as 5-Whys, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.Support internal and external quality audits (e.g. customers, ISO, etc.).Manage the compilation, review, and trending of quality system metrics for Quality Review Board, Management Review Board, and operational metric reporting.Establish sustainable and robust process for phase appropriate CGMP production and technology transfer of products through these phases, both internal and external.Supervise subordinate employees, including training, employee development, and performance management.Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.Perform other functions and duties as required.Qualifications

BS Degree in scientific discipline with advanced degrees or certifications highly desired.Quality or Operations professional with a minimum of 10 years 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.The anticipated salary range for this position is $193,000 - $229,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.TriLink BioTechnologies offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.TriLink BioTechnologies, part of 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.

#J-18808-Ljbffr