8 days old

Manager/Senior Manager, QA

Venatorx Pharmaceuticals, Inc
Malvern, PA 19355
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Venatorx Pharmaceuticals, Inc

Full Time
Mgr & Dir - R&D/Ops
Malvern, PA, US

The Manager/Senior Manager, QA supports GMP Quality Assurance in maintaining Quality Systems related to clinical development, manufacture and testing of clinical supplies and future commercial product for Venatorx. The Manager/Senior Manager, QA ensures the Quality Systems are maintained, including control over the documentation required for regulatory submissions. The position also participates in and contributes to oversight of manufacturing/testing operations at third party organizations.
Responsibilities include:
  • Maintain GMP compliance for Venatorx programs to support clinical studies and future product registration.
  • Support the development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance to applicable Venatorx SOPs, GMP regulations and applicable country specific standards.
  • Provide GMP Quality Assurance oversight of vendors.
  • Manage the compliance (GMP) auditing program to fulfill regulatory requirements.
  • Write and review GMP Standard Operating Procedures.
  • Responsible for reviewing batch manufacturing records, clinical packaging records, associated batch record documents, validation protocols and reports.
  • Responsible for reviewing and tracking internal and contract organization OOS, deviations, change controls, and product complaint investigations.
  • Assist with ensuring CAPA findings from GMP audits and regulatory inspections are effectively addressed and closed.
  • Provide expertise and guidance to Venatorx departments in interpreting and implementing governmental and agency guidelines to assure GMP compliance.
  • Follow applicable regulations, including FDA, ICH, GMP, and Venatorx policies and procedures.
  • Represent QA at CMC project team meetings and contract organization meetings.
  • Provide Quality support to overall product Stability Programs.
  • Perform Quality Review of Regulatory Submissions.
  • Participate in internal and external audits.
  • Participate in regulatory inspections.
Candidate requirements:
  • BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education and experience.
  • 5-7 years of relevant and current work experience in pharmaceutical industry, Quality Assurance required.
  • Previous experience working with contract facilities (laboratories, manufacturers, packagers, distributors, and wholesalers) .
  • Experience with developing relationships and influencing performance outcomes by external partners.
  • Ability to work under challenging deadlines and be accountable for completing work within specific project timelines.
  • Strong detail orientation, organization and focus on quality work product.
  • Proficient in MS Office Suite, Quality systems, electronic document management systems (eDMS).
  • Proven ability to establish new quality systems and optimize existing systems, review documentation, processes and procedures, identify issues, assess compliance, communicate findings clearly and succinctly.
  • Excellent verbal and written communication skills.
  • Demonstrated technical and analytical thinking in resolving issues of critical importance.

Equal Employment Opportunity/M/F/disability/protected veteran status

Posted: 2020-11-20 Expires: 2020-12-22

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Manager/Senior Manager, QA

Venatorx Pharmaceuticals, Inc
Malvern, PA 19355

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