At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.
The Director of Quality Operations provides management oversight in varying areas from document management, training, change management, and CAPA management. The primary responsibility is to direct the quality management activities across multiple product lines covering commercial systems (GDP, OIG), clinical systems (GCP, GVP), a manufacturing information systems (GMP). Additional responsibility is to support the audit management function by presenting QAU operations during customer audits.
What You'll Do
- Develop and coach a growing team of quality professionals
- Optimize organizational structure to adapt to the fast-growing needs of the business
- Create QRB metrics to measure performance and identify robust continuous improvement actions
- Collaborate and influence other functions to deliver on site and company goals
- Ensure all product-related deviations, CAPAs, are initiated, investigated and resolved.
- Ensure that corporate training curriculum is right-sized, compliant, monitored and reported.
- Ensure process control measures are in place and followed
- Works on multiple assignments in collaboration with various department system owners.
- BS/BA + 10 yrs. experience or MS/MA + 8 yrs. experience in a GxP related field within a biotechnology, medical device, or pharmaceutical company.
- Minimum of 5-7 years of management experience.
- Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
- In-depth knowledge of and ability to interpret and apply GxPs, EU, FDA and ICH regulations, guidelines, and industry best practices (e.g., ISPE, DIA, PIC/S) specifically around IT and software development
- Ability to effectively negotiate and build collaboration amongst individuals
- Demonstrated ability to train, manage, and coach staff
- Demonstrated ability in leadership roles
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Nice to have
- ASQ or CISA certification
- Exposure to Agile SDLC, SaaS, and/or IT cloud technologies
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.