Quality Manager

Wedgewood Pharmacy   •  

Swedesboro, NJ

8 - 10 years

Posted 239 days ago

This job is no longer available.

Wedgewood Pharmacy is seeking a Quality Manager to own the Quality Compliance of Incoming Quality, Quality Control and Document Control and participates in developing a quality culture that supports the company’s values of customer focus, integrity, collaboration, and innovation while meeting the needs of our stakeholders and regulators. The Quality Manager leads and manages direct reports and ensures their activities occur in accordance with USP 795, USP 797, State Board of Pharmacy regulations, Section 503A of the Federal FD&C Act and company policies and procedures. Responsibilities include but are not limited to: supporting quality system implementation and maintenance; reviewing and approving documentation; vendor management; and collaboratively working with all functional areas.

Essential Functions:

  • Stays current with applicable laws, federal and pharmacy regulations and company quality standards
  • Contributes to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of compounding activities
  • Prepares and/or reviews/approves controlled documents (e.g. SOP’s, Work Instructions, Specifications, Protocols)
  • Reviews and approves while ensuring root cause and impact were assessed and appropriate Corrective and Preventive Actions (CAPAs) are identified and assigned before closing nonconformances such as: deviations, planned deviations, out of specifications (OOSs), batch failures, and product quality complaints
  • Reviews and approves change controls ensuring adequate justification, impact assessment and implementation plan
  • Reviews and approves executed validation documents ensuring specifications were met and if not, deviations were investigated and resolved
  • Creates Vendor Management Program including qualification and maintenance of vendors
  • Ensures direct reports are efficiently and effectively allocated to support customer expectations and the needs of the business
  • Evaluates the performance of direct reports
  • Participates in cross functional teams in preparation for regulatory inspections, quality agreements, internal and external audits, validation activities and special projects
  • Supports quality system creation/implementation as assigned by Quality Director
  • Provides metrics/trends to Quality Director
  • Other duties as assigned by Quality Director

Qualifications

Required Skills & Abilities:

  • Strong understanding of GMP principles including 21CFR Parts 210 and 211, ICH guidelines, & FDA requirements for APIs and drugs
  • Excellent written, verbal communication and presentation skills
  • Strong analytical abilities coupled with creative problem solving skills
  • Strong organizational skills and attention to detail
  • Ability to work in a dynamic, fast paced and timeline-driven environment with shifting priorities
  • Proficiency with computers and MS Office applications
  • Experience with 21CFR Part 11 complaint quality management systems
  • Experience interfacing with regulatory agencies (e.g. FDA)
  • Experienceauditing and managing API brokers/manufacturers, contract manufacturing organizations and or contract testing laboratories
  • Ability/willingness travel up to 20%

Required Credentials:

  • Bachelor’s degree in scientific/technical discipline
  • 7+ years’ experience in the biotech/biopharm/medical device/pharma industry
  • 5+ years’ working in progressively responsible positions in quality
  • 3+ years’ experience managing staff and providing effective leadership to direct reports
  • Experience in a Quality role that included final closure review of deviation and or OOS and corresponding batch disposition determination.