What is the role of a Associate Director - Quality Assurance at ZYLIDAC BIO LLC?

The Associate Director - Quality Assurance position at ZYLIDAC BIO LLC is a Full-time or part-time position opportunity in the Information Technology field.

Where is this Associate Director - Quality Assurance job located?

Emeryville, California, 94608, United States

What type of employment is offered for this Associate Director - Quality Assurance role?

Full-time or part-time position

What is the expected salary for this Associate Director - Quality Assurance job?

$150,000 – $180,000 Yearly Salary

How can I apply for the Associate Director - Quality Assurance position at ZYLIDAC BIO LLC?

You can apply directly through the application link provided.

Associate Director - Quality Assurance at ZYLIDAC BIO LLC | Jobs and Employment

Description:

Maintain QA and cGMP compliance for all aspects of the program development and manufacturing to support CDMO operations
Write, review, approve, and maintain cGMP documentation (SOPs, protocols, technical reports, etc.)
Establish, oversee, and maintain Standard Operation Procedures for the site
Oversee execution of Quality Systems such as Change Control, complaint investigations deviation management, and risk assessment
Assist/lead cGMP inspections of outside contract testing laboratories and monitor to ensure cGMP/GLP compliance
Develop, negotiate, and maintain Quality Agreements with contract testing labs or customers and ensure requirements are met and enforced
Interact with cross-function personnel (development, manufacturing, QC and Facilities Engineering) and contract test facilities to biologics development and manufacturing through release and ongoing stability testing
Direct batch record review and lot disposition activities to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
Support equipment, utility, and facility qualification/validation activities
Approve analytical method validations strategy and protocols/reports
Approve process and product validation strategy, protocols and reports
Participate in the preparation and review of some sections of regulatory submissions
Support external and internal audits as required

Requirements:

BS (or equivalent) in a scientific related field with a minimum of 7 years’ experience in the pharmaceutical/biotech industry
Minimum of 5 years in Quality Assurance, preferably in the biologics field
Working knowledge and technical understanding of the manufacture and testing of biologics
Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
Working knowledge of cGMP principles with respect to FDA and EMA regulations
Working knowledge of cGCP a plus
Experience working with contract manufacturing and testing facilities; experience with interacting with Qualified Persons
Highly organized and ability to manage multiple priorities
Ability to work independently and with various work groups
Strong attention to detail and excellent organization
Excellent verbal and written communication, including interpersonal skills strongly preferred
Ability to interact with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
Ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to relationship with Quality while maintaining compliance.
Ability to work on complex issues where analysis of situations or data requires an in-depth knowledge or process understanding.
Ability to participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.

Associate Director - Quality Assurance at ZYLIDAC BIO LLC – Emeryville, California

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