Principal Product Quality Leader
Aequor JD ·www.aequor.com
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Fully Remote - Flexible working hours.
Prior *** experience
Pharma or biotech experience
*** s corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
You will support one or more of ***'s late-stage or commercial synthetic products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such as change control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.
Primary Responsibilities include the following:
Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
Conduct science and risk-based evaluation of complex process and product quality data
Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
Extract and analyze data from various sources and Quality systems
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
*** offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we re employing are not only new to *** but are new to the industry as a whole. Help us to pave new roads for helping patients.
Prior *** experience
Pharma or biotech experience
*** s corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
You will support one or more of ***'s late-stage or commercial synthetic products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such as change control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.
Primary Responsibilities include the following:
Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
Conduct science and risk-based evaluation of complex process and product quality data
Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
Extract and analyze data from various sources and Quality systems
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
*** offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we re employing are not only new to *** but are new to the industry as a whole. Help us to pave new roads for helping patients.
Frequently asked questions
Who is hiring for the Principal Product Quality Leader role?
Aequor JD is hiring for the Principal Product Quality Leader position, a Shazamme client. Apply directly on the employer's career site.
Where is the Principal Product Quality Leader job located?
The Principal Product Quality Leader role with Aequor JD is based in US. The role is remote-friendly.
Is the Principal Product Quality Leader role remote?
Yes — the Principal Product Quality Leader position at Aequor JD is remote. Candidates based in US are preferred.
Is the Principal Product Quality Leader role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Principal Product Quality Leader role?
The Principal Product Quality Leader position is aimed at principal-level candidates.
How do I apply for the Principal Product Quality Leader role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.