Head of Site Quality

3 weeks ago


Decatur, United States CareerBuilder Full time

Reports To:

VP of Regulatory Affairs and
Quality Assurance

Work Location:

Decatur, Illinois
Position Summary:
This position will manage and drive the qualification process at Risings 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.
Preparing Decatur sites for FDA readiness, managing FDA inspections, internal audits/external
audits
Build and manage effective quality Unit, comprising of various QA functions, Microbiology
and QC Laborator
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 function. 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/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 CAPAs and Changes
Ensure compliance with all pre and post approval commitments
Position Requirements:
Education:
Required:

Advanced scientific degree (Master of Science, PharmD, PhD) preferred, or
Bachelors degree with relevant experience

Experience:

Required:

At least 15 years of Quality experience in Sterile Pharmaceutical or
Biopharmaceutical space. At least 5 years of Quality experience at a management level of site quality function

Specialized Training or Technical Knowledge Licenses, Certifications Needed:
Working knowledge of MS Word, Excel, Outlook, and Power Point
Working knowledge of Adobe Acrobat
Functional Knowledge:
Excellent conceptualizing, analytical, people management and problem-solving skills
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
Rising Pharmaceuticals Launches Edetate Calcium Disodium Injection, an Important Antidote Treatment to Address Lead Poisoning.
From our manufacturers, partners and pharmacies to physicians and their patients, our goal is to make life better for everyone we impact.

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