QA Manager - Private Labeled Product (569)

 Job Description

The Quality Assurance Manager will join the Civica, Inc. (“Civica”) team in supplying essential generic quality medicines to our hospital members in the United States by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The Quality Assurance Manager will provide quality oversight within the Quality System, including but not limited to review of SOPs, protocols, reports, data and records generated to support the disposition and distribution of pharmaceutical product to meet business and operational requirements. The Quality Assurance Manager will develop processes and procedures in support of the Quality Management system consistent with Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs).

The Quality Assurance Manager will have a minimum five (5) years related experience in process improvement, analyzing information, strategic planning, verbal communication, informing others, emphasizing excellence, attention to detail, thoroughness, dealing with complexity and/or training and qualified to lead and manage all aspects of the quality assurance process.

Essential Duties and Responsibilities:

·      • Leads qualification and approval of Private Labeled (PLD) suppliers and subcontractors.

o  Works with supply chain to assure serialization is completed with PLD suppliers

o  Leads Quality Agreement negotiations with CMO Partners

·      Routine coordination and quality review of Contract Manufacturer Organization (CMO) Partners’ documentation including batch record review for compliance to facilitate timely disposition of product lots.

• Provides input and quality oversight over investigations, which includes review of investigation reports and associated corrective and preventative action (CAPA) plans.

·      Manages changes coming from the CMOs within the Civica Quality System

·      Partners with supply chain to ensure issues are resolved by the CMO to maintain product availability

·      Support product complaint investigations ensuring timely response by CMOs

·      Monitor serialization processes and vendors in relation to DSCSA.

·      Perform lot disposition for materials received at 3PL.

·      Support CGMP compliance and inspection readiness within organization.

·      Identify and implement continuous improvement opportunities

·      Support CGMP compliance and inspection readiness within organization.

·      Reviews records to ensure data meets the industry requirements for data integrity.

·      Ensures that procedures are being followed as outlined under FDA, ISO, USP and CGMP guidelines.

Minimum Qualifications and Capabilities:

Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the pharmaceutical industry. Experience in the manufacture of sterile injectable pharmaceutical products required.

Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.

Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.

Ability to work autonomously within established guidelines, procedures and practices.

Committed to delivering high quality results, overcoming challenges and focusing on what matters.

Continuously looking for opportunities to learn, build skills and share learning.

Preferred Qualifications:

Experience with commercial distribution of pharmaceuticals is preferred. Experience with quality support of serialization processes is preferred.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.