Back to all jobs

Quality Manager (Pharmaceutical CMO’s)

Global Pharmaceutical Manufacturing Company has an immediate opening for a Quality Manager External Supply to join their dynamic quality team in Bethlehem, PA. Company offers excellent compensation and benefits package as well as a very collaborative and friendly work environment.  Bonus target 15%

Purpose of Job:

  • Ensure External Product Suppliers are meeting their contracts in line with our core values & ethical practices.
  • Ensure systems at all sites for external suppliers are in synchronization with current regulations & customers’ expectations.
  • Assure the quality of external supplier products and processes by establishing and enforcing quality standards.
  • Act as contact point between the CMO and company to ensure all activities related to quality, regulatory, supply chain are fast-tracked to ensure on-time supply of medicines to patients. Job Description:
  • Provides leadership and compliance in the area of QA /QC support at CMOs ensuring a secure supply of high quality products
  • Ensures implementation of QMS requirements per regulatory and Company requirements at CMOs and product is getting manufactured at the site per cGMP requirements
  • Provides support in the area of regulatory compliance at CMO to ensure no disruption to supply and no regulatory punitive action
  • Supports the business and CMO by timely release and delivery of finished products ensuring quick resolution of quality related issues
  • Ensures adequate QA oversight and adequate GMP compliance at the CMO sites for new and current products including process validation, master documentation approval and the implementation of quality agreements
  • Performs routine audits of CMOs, follow-up for CAPA actions and tracks to closure and maintenance of an updated audit schedule
  • Supports CMOs in response to regulatory queries and deficiencies
  • Conducts supplier reviews and approvals including planning, performing and documentation of audits as well as tracking audit-finding closure to completion
  • Supports QP with documents and any other activities that maybe required for batch release and oversight by QP for EU/UK market
  • Coordinates with EU Quality team (if required), CMO quality team and CMO for smooth and quick release of products for the EU market
  • Authors, reviews and/or approves change controls, deviations and other QMS documents raised internally or at CMOs
  • Manages customer complaints at external sites including initiation of internal tracking documents, assignment of action items and complaint resolution
  • Monitors and reviews PPRs for all products made for Company and implement corrective actions arising out of PPR review and where required, prepares and authors product reviews
  • Ensures well-defined stability program in place for Company products, reviews stability data and initiates relevant actions if any significant changes/failures are identified
  • Reviews and issues revised artworks to CMO and ensures that current versions are used
  • Prepares, reviews and approves quality documentation including Quality Agreements
  • Ensures all CMOs have a valid Quality agreement in place
  • Participates and contributes in management review meetings within Company for CMOs under scope and reports KPIs to management monthly
  • Responsible for technical coordination with different functions within Company to ensure faster resolution and approvals for change control, deviations, complaints and other investigations
  • Handles quality issues related to raw and packaging materials, review and approve destruction of materials, coordination with supply chain and other teams within Company
  • Provides support to Regulatory affairs for annual reports, regulatory filings and variations and filing of FARs where required
  • Reviews and approves artwork and ensures only current versions are used
  • Provide support to CMO to continuously improve contribution to business performance management
  • Meets with external manufacturing organizations for discussion and status updates of current manufacturing, complaints and non-conformances
  • Provides support in process validation, API qualification activities. Co-ordinate within Company for review and approvals, and support for regulatory submissions and filings
  • Provides support to Business development and sales team for launch of products in newer markets, by ensuring smooth flow of information from the CMO to the respective teams
  • Supports product and site diligence activities as required by business
  • Supports activities related to CMO Quality operations like preparation of SOPs, Quality road map, document management, training and new initiatives.

Essential Qualifications:

  • Bachelor’s Degree required with focus in Pharmacy or Chemistry, Microbiology, Master’s Degree preferred

Essential Experience:

  • Minimum 10 years’ experience in regulated Pharma companies that use contract manufacturers
  • Minimum 5’ years in sterile formulations
  • Hands on experience of quality systems in a GxP environment
  • Direct experience with FDA required; knowledge of EU GMP MHRA and other health authority inspections preferred
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Pleasing personality, with good adaptability to the surroundings
  • Responsible for CMOs across America’s with travel to CMO sites as required

    • Job type: Permanent
    • Location: Bethlehem
    • Date posted: