Sr. Manager, Quality Control - Method Qualification/Validation

Baltimore, MD, US
Jan 02, 2019
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Sr. Manager, Quality Control will be responsible for oversight of the Quality Control (QC) method qualification and validation program in support of the development and manufacturing services of Phase I through commercial manufacturing.

Key Responsibilities:

  • Establish and manage Paragon's quality control method qualification, validation and transfer programs
  • Participates and carries out continuous quality improvements in the QC laboratory
  • Assist with identification and resolution of Paragon analytical development and quality control test method issues
  • Ensures compliance with cGMP and safety requirements within the QC laboratory
  • Works with Analytical Development and Quality Assurance to schedule method qualification protocol generation, testing, review and approval
  • Works with Analytical Development and Quality Assurance on method transfer packages
  • Reviews and approves SOPs, STMs and method qualification and validation protocols.
  • Participates in project specific, system, and vendor audits
  • Participates in internal audits of GMP QC data and record as it relates to method qualification and validation
  • Reviews new and executed documents for compliance to stated Paragon SOPs, formats and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.)
  • Conducts training on applicable SOPs, regulatory requirements and quality initiatives
  • Provide input to quality metrics specific to QC method qualification/validation
  • Work with QC Lab Management to maintains QC laboratories in an audit ready status always.
  • Participate in client meetings regarding method qualification and validation
  • Acts as technical QC SME for method qualification and validation during third party inspections/audits.

Experience & Education:

  • Bachelor degree in a science or analytical discipline
  • 10 years experience in Quality Control with 8 of those years in an analytical method development, qualification and validation role required
  • 4 years leadership experience including performance management
  • Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance's (US and EU) specifically related to method qualification and validation.
  • Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.
  • Ability to analyze information and solve problems relating to Quality Control method qualification and validation.
  • LIMS experience preferred.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.