About this position
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
- 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.
Salary Information
$150000.00 - $180000.00
Annual Salary