|Head of Site Quality
|VP of Regulatory Affairs and
|This position will manage and drive the qualification process at Rising’s manufacturing facilities in
Decatur, Illinois. Some key responsibilities include building and leading effective quality unit,
effective management of quality systems and implementing a quality culture which strives towards
compliance, patient safety, and continuous improvements. This position will directly manage key
quality functions, such as quality assurance, quality control, sterility assurance, and microbiology.
The Head of Site Quality will prepare the Decatur sites towards all-time FDA readiness and function as
the key point of contact during FDA inspections and interactions.
|Essential Duties & Responsibilities:
|• Preparing Decatur sites for FDA readiness, managing FDA inspections, internal audits/external
|• Build and manage effective quality unit comprised of various QA functions, including microbiology.
and QC Laboratory
|• Promote a positive quality culture with effective oversight over critical quality systems and
operations resulting in high-quality, sterile pharmaceutical products.
|• Leading and directing the Aseptic Processing/Sterility Assurance team, providing hands-on
guidance and support to ensure the team is successful in meeting their objectives.
|• Implement and oversee data integrity controls in manufacturing and laboratory functions. This
includes effective quality review of critical data integrity controls, critical material attributes,
process parameters and critical quality attributes to ensure products comply with FDA
regulations and deliver sustainable quality to meet patient needs.
|• Implement a robust Sterility Assurance and Contamination Control Strategy
|• Developing and implementing learning and development opportunities for team
members to enhance their skills and abilities
|• Establishes and reviews Quality Metrics to track and trend key parameters for quality compliance.
quality operations and continuous improvement
|• Works with site head, corporate and senior stakeholders to develop quality budgets and
strategy to support sustainable growth.
|• Collaborate with FDA as the need arises, representing the firm to authorities and regulatory
inspectorates in matters relating to GMP
|• Developing and implementing learning and development opportunities for team members to
enhance their skills and abilities
|• Lead the site in regulatory inspections and customer audits
|• Developing and implementing learning and development opportunities for team members
to enhance their skills and abilities
|• Oversee implementation of effective and timely CAPA’s and Changes
|• Ensure compliance with all pre- and post-approval commitments
|Specialized Training or Technical Knowledge Licenses and Certifications Needed:
|• Effective written and oral communication skills
|• Strong organizational, planning, and communication skills
|• Demonstrates exceptional time management skills.
|• Using logic and reasoning to identify solutions to problems
|• Ability to multi-task, set priorities, and meet strict deadlines
|• Ability to lead, motivate, coach, and teach others