A clinical-stage pharmaceutical company focused on the discovery and development of novel small molecule pharmaceuticals for the treatment of cancer and other major diseases is hiring a GMP Quality Assurance professional.
Participate in quality oversight of all outsourced operations related to raw material, in-process, and finished good production activities, including warehousing and distribution.
Review and evaluate pre-executed and executed Batch Production Records for API, Drug Product, Packaging and Labelling
Prepare disposition of clinical and commercial products.
Review and approve specifications
Review and approve label proofs and packaging customer requests for clinical trials in domestic and international markets.
Review and approve packaging components specifications, label proofs and artwork for commercial labeling operations
Review non-compliance events that occur during production and testing, collaborate with CMOs and CTOs on investigations and support remediation, as required.
Review and approve quality systems in Veeva such as deviations, change control, CAPA,…
Assure that source data and information used in regulatory submissions and validation activities is accurate and traceable.
Partner with QC to review/approve manufacturing testing data as well as protocols and reports associated with stability, method validation and method transfer, as needed.
Support the Quality Management Review.
Prepare Annual Product Quality Review.
Track QA KPIs and prepare dashboards.
Review and approve SOPs
Establish/maintain effective relationships with vendors.
Ensure quality expectations are being met in the areas of Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and Good Documentation Practice.
Participate and contribute to regular meetings held by the Quality organization, and represent Quality at cross-functional meetings and improvement initiatives.
B.S. in Life Sciences or related science degree (Chemistry, Biochemistry, etc.) required (an advanced degree in a related field is a plus)
5 -8 years of experience in QA and/or QC within the Pharmaceutical or Biotechnology industry in an operational QA role
Experience with manufacturing and packaging/labeling batch record review
Experience with data review for accuracy, completeness and compliance
Experience with the CMC and Regulatory Filing requirements
Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations
Understanding of product process and development, from discovery to commercialization is a plus
Experience with small molecules and oral dosage forms is a plus
Knowledgeable in FDA cGMP regulations, EMA, MHRA, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.