Director, QA Operations (Quality Events and Data Analytics)

Avid Bioservices•Tustin, CA

1d•Onsite

About The Position

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. The Director, QA Operations (Quality Events and Data Analytics) is responsible for leading the execution and oversight of quality event processes (deviations, CAPA, complaints, and OOS) in support of manufacturing operations. This role is part of the QA Operations organization and focuses on real-time quality event management, operational support, and continuous improvement. Responsibility for enterprise Quality Systems (including document control, change control and Quality Risk Management) resides within separate functions.

Requirements

B.A. or B.S. degree (preferably in Life Science) is required with at least 7 - 10 years of experience in the pharmaceutical or biopharmaceutical industry.
Must have sound knowledge of cGMPs and a basic knowledge of biologics manufacturing.
The ability to interpret and relate Quality standards for implementation is essential along with the ability to make sound decisions that align with cGMPs.
Must be able to communicate clearly and professionally both in writing and verbally.
Flexibility in problem solving, providing direction and work hours to meet business objectives is essential.
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, public groups and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
Ability to deal with a variety of abstract and concrete variables.
Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc.
Microsoft Office experience preferred (Excel, Word, PowerPoint).

Nice To Haves

Six Sigma Black Belt and 3+ years Operational Excellence experience.

Responsibilities

Manage the QA team responsible for the review and approval of Deviation, CAPA, OOS and Complaints.
Responsible for execution, oversight, and continuous improvement of quality event processes within QA Operations. This includes establishing quality standards for deviations (investigation, root cause analysis, impact, CAPAs, and effectiveness); ensuring that event records are completed on time with robust output commensurate with the complexity of the event and meet cGMP expectations.
Develop KPIs and perform detailed analytical trending of quality events individually and as a collective.
Present analytics to governance meetings; proactively identify and implement improvement measures based on the analysis.
Identify, design, champion and implement process improvements using Operational Excellence tools to analyze current state and create future state.
Work cross functionally with Operations leadership to identify and implement robust preventive actions to minimize the rate of controllable quality events and ensure an effective quality management system.
Utilize technical and quality knowledge to provide QA oversight and guidance to real-time Manufacturing floor events resulting in rapid remediation and compliance to client and regulatory expectations.
Communicate clearly with clients to support issue resolution and client relations.
Independently formulate solutions to complex problems with little guidance or oversight required.
Manage/direct the selection, training, motivation, development, appraisal and work assignments of Quality personnel.
Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings.