Head of Site Quality

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Position Title:	Head of Site Quality	Department:	Quality
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 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
audits

• 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

Position Requirements:
Education:
Required:	Advanced scientific degree (Master of Science, PharmD, PhD) preferred, or Bachelor’s 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 the management level of site quality function

Specialized Training or Technical Knowledge Licenses and Certifications Needed:
Required:	Working knowledge of MS Word, Excel, Outlook, and Power Point Working knowledge of Adobe Acrobat

Functional Knowledge:
Required:	Excellent conceptualizing, analytical, people management and problem-solving skills Working knowledge of Adobe Acrobat

Job-Specific Competencies:

• 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

Application Form

Rising Pharmaceuticals Bolsters U.S. Supply Chain by Expanding Sterile Dosage Capabilities, Including Injectables and Ophthalmics, with Opening of New Facility

Head of Site Quality

Application Form

Integrity

Responsibility

Service

Collaboration

Teamwork