Senior Quality Systems Validation Engineer (Process and Method)

Quality Cambridge, MA


Description

What’s in it for you?

As the Senior Quality Engineer (Process and Method Validation), you be responsible for quality oversight of validation activities, particularly process and method validation. In this position, you will ensure compliance with applicable regulations in support of GxP compliant programs, cGMP manufacturing and CMC activities, both internally and with external partners.  Reporting to the Associate Director of Quality Systems, you will drive critical processes, initiatives, and strategy for the QS department.

What will you do?

  • Provide oversight and guidance to ensure that GMP standards and regulatory requirements related to process validation and method validation are adhered to in projects both internally and with external partners.
  • Provide oversight and guidance of validation and qualification activities for internal equipment, analytical instruments, and computer systems.
  • Participate in or moderate cross-functional risk assessments to define the scope of validation activities.
  • Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
  • Act as Subject Matter Expert in the assessment and execution of deviations, corrective and preventive actions, and change controls.
  • Assist the department in developing programs and procedures to meet current industry standards, internal and external regulatory requirements.
  • Create and manage metrics to support trending and management review.
  • Lead and/or participate in internal audits as needed to support GxP activities.
  • Support external regulatory, customer and third-party audits.
  • Manage projects in a cross functional environment that drives quality compliance and continuous improvement.
  • Mentor less experienced personnel to support development and growth of more junior staff.

What are we looking for?

  • Minimum of a four-year technical degree or equivalent education and work experience
  • Minimum of eight years experience in pharmaceutical, biotech or related health-care industry
  • Minimum of five years experience in QA Validation oversight, specifically for process and method validation
  • Experience mediating risk assessments preferred.
  • Project management experience and/or certification preferred.
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines, and GAMP and USP AIQ methodologies
  • Must have excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
  • Demonstrate strong interpersonal communication skills, ability to work in team environment and excellent organizational skills

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States and Europe for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.