QA Release Manager

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

WHAT WE ARE LOOKING FOR

The incumbent in this role serves as the primary decision maker for final batch disposition (e.g., approve, reject, hold) of finished pharmaceutical products for the Raleigh site. The role is the primary liaison between the site Quality Organization and the site’s Supply Chain group providing information regarding the targeted release of batches based on identified priorities. The role oversees the comprehensive review of the final batch records and supports documentation ensuring that the complete data package is available and reviewed prior to disposition or recommendation. The role ensures that all products recommended for release meets all approved specifications and regulatory requirements; therefore, the incumbent makes critical decisions regarding the quality of each finished product batch, any related deviations or OOS results, and their related resolution / conclusion. Operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

YOUR ROLE

Essential Functions & Responsibilities:

• Lead and manage the batch record review group ensuring timely, accurate and compliant disposition of finished product batches.
• Coordinates cross-functional activities among Production, QC Chemistry, QC Microbiology, QA Investigations, Supply Chain and sometimes Regulatory Affairs.
• Maintains batch disposition records and reports metrics regarding release cycle times, quality trends, and leading / lagging key performance indicators (KPIs) for the use of site-level Executive Leadership and above site-level Executive Leadership.
• Performs QA Functional Review of deviations (Exceptions) and OOS investigations ensuring the investigations meet CGMP standards and are scientifically defensible.
• Reviews and approves batch release-related data in support of Annual Product Quality Reviews (APQRs).
• Supports regulatory inspections and customer-based and internal audits as the primary expert on the batch release system.
• Provides leadership, coaching and mentoring to QA personnel involved in the batch release review and release activities.
• Stays current with industry expectations and regulatory requirements for CGMPs.
• Performs other duties as assigned by management

Department Specific/Non-Essential Functions:

• Ability to work in a dynamic environment with competing priorities while maintaining a compliance focus.
• Willingness to work flexible hours as needed to support product release timelines and corporate goals.
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.  Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.  Report all safety and/or environmental incidents to management immediately.
• Enforce EHS procedures and respond to EHS concerns within area of operational responsibility.  Perform incident investigations and follow through regarding corrective actions.
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry,  Microbiology or a related life science (required).
• Minimum 10 years of progressive Pharmaceut