Proclinical Staffing

Product Quality Lead

3 days left

Location
Dublin, Republic of Ireland
Salary
Negotiable
Posted
23 Feb 2021
Closes
09 Mar 2021
Ref
35848
Contact
Caleb Mensah
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Proclinical has partnered with a leading pharmaceutical company in search for a Product Quality Lead. You will be a representative for a Global Product Team, accountable for consulting and informing stakeholders of relevant quality information.

Job Responsibilities

  • Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers
  • Support quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the operational strategy, GMP requirements and are verified for accuracy and data integrity.
  • Represent Product Quality program in CMC meetings with global regulatory agencies and during regulatory inspections
  • Represent Quality in Global CMC and Commercialization teams
  • Quality lead supporting business growth in product launch, due diligence, divestment and integration activities and works in partnership with relevant stakeholders to influence quality, supply and regulatory strategy.
  • Lead product quality related cross-functional teams
  • Maintain oversight of product performance and develop countermeasures via strategic and tactical quality input to develop sustainable compliant product with continuity of supply.
  • Supports the Incident Escalation process.
  • Support the definition of product critical quality attributes, deliver and drive control strategy, deliver phase-appropriate product specifications.
  • Provide quality oversight and guidance during product launch
  • Provide strategic guidance in support of the timely implementation of multi-site global changes with regulatory impact
  • Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase
  • For development products, develops product knowledge repositories and utilises product expertise to support the product throughout lifecycle. Supporting Risk Management program and owner of corresponding actions.
  • Support the establishment of preferred Supply Chain architecture. In collaboration with relevant stakeholder's, develops recommendations which improve product, process and
  • Supply chain architecture strategies and establishes key product launch considerations, attributes and profiles for those product nearing commercialization

Skills and Requirements

Science or Technology degree in a relevant disciplineMinimum 7 years Biopharmaceutical or Life Sciences industry experienceStrong knowledge of GMP & GDP regulations, FDA 21 CFR, EU GMP and ICH GuidelinesExperience managing supplier audits, quality agreements, change notifications, deviations and CAPA management

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-CM1

Apply for Product Quality Lead

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs