Quality Assurance Manager

Proclinical is currently recruiting for a Quality Assurance Manager with a pharmaceutical company located in Lexington, MA.

Job Responsibilities:

• Assists with the prioritization and coordination of batch release activities, to prevent supply disruption.
  * Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to company requirements and SAP inspection plans.
  * Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into company systems e.g. LabLIMS and SAP/BPR
  * Prepare and review batch documentation for release, including upload of batch certificates to the repository.
  * Archive batch documentation according to company and customer requirements.
  * Perform Technical Release of products in SAP/BPR based on release certificates from Contract Manufacturers/ Suppliers
  * Support other functions as needed with e.g. PQR preparation, deviations, change controls, and CAPA.
  * Maintenance of product lists and Quality relevant SAP master data.
  * Provides other support/input as needed to ensure the effective oversight of Contract Manufacturers/Suppliers and compliance of OncESSM procedure/processes with company requirements, and GMP.
  * Provides Quality oversight for Artwork changes for product manufactured in the US.

Skills and Requirements:

• Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
  * Minimum 6 years of QA/QC experience in the pharmaceutical industry
  * Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
  * Analytical Skills - ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
  * Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management
  * Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
  * Regulatory Understanding - broad based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging
  * Knowledge and understanding of relevant pharmaceutical regulations in US, Japan, Europe and relevant markets.
  * Knowledge and experience of Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products)
  * Knowledge of LEAN and Continuous Improvement tools.
  Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
  * Ability to make risk based Quality decisions impacting products and services within scope of oversight, and prioritize accordingly. Ability to elevate organizational performance by partner with stakeholders.
• Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
  * Responsible for day to day disposition decision with CMO/CTL.
  * Responsible for escalating any issues identified during review of manufacturing/analytical information provided from CMO/CTLs.
  * Interacts with stakeholders, regulators, industry peers and other quality units.
  Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
  * Accountable for supporting disposition activities at CMOs or CTLs for Oncology and Small Molecule commercial products.

If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.

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

Proclinical Staffing is an equal opportunity employer.

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