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Quality Assurance Manager/Director

Employer
Ascendia Pharmaceuticals LLC
Location
North Brunswick, NJ
Start date
Dec 19, 2018

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Discipline
Quality, Quality Assurance, Science/R&D, Chemistry
Required Education
Bachelors Degree
Position Type
Full time

About Ascendia Pharmaceuticals:

Ascendia is a specialty CDMO company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates.  Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies.  Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-particles, injectable, and oral controlled release.  Ascendia provides development and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.

The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over their disease and enhance quality of life. 

About the Position:

The Manager or Director of Quality Assurance is responsible for the design, development, execution, and administration/maintenance of a GxP Quality Management System meeting applicable compliance requirements and Regulatory Agencies with respect to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

The successful candidate will be responsible for maintaining the Quality Assurance audit database, managing the CAPA/deviation documentation and tracking system, auditing/reviewing internal and external documents, maintain the company’s training records, as well as provide overall Quality oversight to the manufacturing process.

Principle Responsibilities

  • Represent Quality Assurance in internal and external meetings to ensure quality compliance requirements are met.
  • Assist business functional areas in developing and implementing processes, procedures, and systems to perform critical activities in an efficient and effective manner to ensure compliance with applicable regulations and company standards.
  • Develop and implement and/or revise corporate standard documents relating to GxPs such as quality manuals, policies, SOPs, work instructions, forms, reference documents, in collaboration with relevant business functions.
  • Develop, execute, and maintain the document control system to ensure appropriate level of Quality oversight to GxP documentation.
  • Review and update quality manuals, SOPs, policies and processes regularly to ensure all quality standards are in compliance with GxP standards, FDA/EMA/PMDA/ICH and other applicable competent authority regulations and requirements.
  • Conduct and/or manage internal and external audits to ensure compliance to all relevant policies and procedures as required. This includes the issuance of audit reports and facilitation of timely closure of corrective actions by the respective departments.
  • Ensure continuous inspection readiness.
  • Lead the participation, coordination, and responses to audits and inspections.
  • Administer, develop, and maintain the employee training program including assessments of its’ effectiveness, in collaboration with business functions. Specifically: coordinate, develop, and prepare training materials (e.g., presentations) and training sessions, identify and schedule training opportunities for applicable personnel, and periodically audit site personnel training files.
  • Ensure compliance of manufacture and testing of product for clinical studies. Lead in resolution of quality non-compliance issues in production and testing at labs or at vendors. Identify areas of improvement.
  • Establish and maintain appropriate development phase GMP compliance for product manufacture, testing, and stability; review and assess production and testing methods, specifications, validations, reference materials and test results.
  • Review applicable documentation from internal and external sources as well as applicable sections of regulatory submissions for compliance with documentation, established standards, and regulations.
  • Approve clinical investigation medicinal product label text and proofs for release to production, ensuring proper quality and compliance standards are met, as required.

Qualifications

  • Minimum Bachelor’s degree in chemistry, QA, engineering, pharmacy, science, pharmaceutical sciences, or related fields.
  • Minimum 5 years of experience in Quality Assurance with experience working with GMP pharmaceutical development, manufactur.ng, testing and facility.
  • Preferred hand-on experience with product development for non-sterile dosage forms, understanding the requirements of different clinical phase of product development. Technical knowledge of analytical method qualification, process validation, establishing product specifications, and facility qualification.
  • Experience in working in compliance with US, EU, and ICH GMP requirements, experience with writing or reviewing submission documentation, responses to regulatory inquiries and inspections.
  • Experience with regulatory compliance inspections. Proficiency with interpreting and implementing GXPs, FDA, EMA, ISO and ICH Regulations and guidelines
  • Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
  • Strong interpersonal skills to effectively communicate with teams, peers, management, and external contacts.
  • Prior experience operating in biotech or pharma and managing change control programs in the pharmaceutical industry. Broad knowledge of quality systems utilized in pharmaceutical industries.
  •  Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

EEO/AA M/F/V/D

Please visit our website at www.ascendiapharma.com for more information. To apply, please submit your CV or resume.

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