Associate Director, QC Operations

Location
Foster City, California, United States
Posted
Jul 25, 2021
Ref
202846841
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Vaccine Product Development organization as an Associate Director of QC Operations.

The position will be an integral part of the team implementing and maintaining cGMP-compliance in routine operations for all phases of clinical development. The primary responsibility will include having oversight of the quality control including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations. This individual will build systems/processes and organize resources to establish and achieve product release cycle times to meet project due dates and deliverables in a highly collaborative and cross-functional environment. The ideal candidate will apply strong leadership and cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches

Essential Functions:

• Recruit, hire and build a collaborative and high performing QC team.

• Collaborate with Quality team and interface with key stake-holders to establish and maintain cGMP-compliant quality control operations, including establishing a new QC laboratory (programming, equipment purchase/qualification, process documentation) as needed.

• Provide technical and strategic functional oversight, including resource/operational

management for all QC areas (physicochemical, biological and microbial).

• Accountable for execution of quality control testing and supportive processes including sample and inventory management, scheduling, documentation, compliance review, results reporting (CoA), and scientific interpretation of data / method performance to ensure high quality data and control of methods.

• Establish processes control, charting and trending of lot release data

• Establish processes, controls and metrics within QC operations for life cycle management of methods and programs

• Manage qualification and retest of critical reagents and reference standard program

• Collaborate with QC of Method Transfer and Validation to support related activities

• Manage outsourced cGMP testing supporting lot release

• Accountable for quality event management (deviations, investigations, change control).

• Support audits, inspections and health authority responses

• Guide and work with others to identify opportunities for continuous improvement and

implement/maintain solutions

• Provide strong leadership in establishing a quality culture and shared accountability. Ensure

GMP compliance is built into the design and implementation of processes and systems,

including tracking metrics to monitor and improve performance

Requirements:

• MS or BS with 15+ years of industry experience in Pharma / Biotech industry required

• Demonstrate sound complex decision making skills and exhibit good judgment. Make

decision with understanding of the strategic context and short and long term impact of

decisions on other departments or functional areas before making them; able to decide and act effectively without having the whole picture;

• Result oriented; good judgment in directing attention and effort across competing

priorities, especially when resource constrained; implements best practices or leading-edge quality standards;

• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management

• Track record of building strong functional team, able to leverages understanding of

strengths and weaknesses of team members in positioning them in the team; ability to

anticipate and implements changes in roles and accountabilities in response to changes in the work environment; ensures teams have the right mix of talent and resources to

meet/exceed goals;

• Solid understanding of product development activities in biotech/drug/vaccine

development, including key interdependencies, and knowledge of proven development

strategies and tactics

• Expert analytical skills for integrating and interpreting interdisciplinary project

information; thorough understanding of the drug/vaccine development process

• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to

analytical method qualification/validation for small molecules, biologics and vaccines,

stability study design and expiry dating

• Demonstrated ability of applying the regulatory guidance to formulate practical solutions

and phase appropriate analytical transfer, validation and stability strategy

• Ability to work globally with CMOs in different countries and continents

• Understanding of various analytical chemistry methodology principles and successful track record of method transfer, trouble shooting and validation for GMP release and stability testing, as well as stability study design and expiry/shelf life establishment

• Self-starter and resourceful problem solver, able to move up learning curve independently and map out intermediate milestones to achieve project goals.

• Experience in IND, NDA and BLA submission is highly preferred

• Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs

• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats

• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members