Manager, R&D Quality Assurance

6/7/21

Burlington, MA 01803

1262

FullTimeRegular

Manager, R&D Quality Assurance

The Manager, Quality Assurance is an integral part of the team, contributing to our success by supporting the Quality Assurance, Quality Control, and Analytical Services Divisions of the R&D/Clinical processes at the site. The candidate will ensure compliant phase appropriate cGMP operations are continuously maintained across the site leading up to project turnover to commercial production. Responsibilities include supporting a partnership with the Quality unit charged with the review and management of departure investigations (i.e., root cause analysis, product impact assessments, and CAPA), GMP document review, on-floor batch review, batch disposition, and also supporting phase appropriate quality oversight during technology transfer. The incumbent will also play a vital role during regulatory agency inspections and client audits as pertaining to R&D/clinical products and processes. The Manager, Quality Assurance will interact with customers through routine production activities for the R&D business unit.

The position assures that all documentation, procedures and protocols comply with all phase appropriate GMP, ICH, FDA, and EU guidelines. In addition, the position provides oversight of document control and implementation and enforcing compliance of all the site’s Standard Operating Procedures and FDA guidelines with a phase appropriate mindset through training and internal audits. The position ensures that any R&D/clinical product produced by the site meets specifications for final release of clinical materials. This includes but is not limited method development for Process Development Projects.

The Manager of QA will work on complex issues where an in-depth knowledge is required and will participate at strategic decisions for the site’s R&D/Clinical business unit operations. The Manager of QA will interact frequently with R&D/clinical customers to ensure that their needs are met guaranteeing the quality of the products and services provided.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities

  • Establish and maintain a risk-based and scientific-based phase appropriate quality system to protect the public health and to meet business needs
  • Through a quality system approach, ensure all GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
  • Set up and establish innovative solutions for early phase pre-clinical and clinical programs to enable QbD strategies
  • Oversee, and be ultimately responsible for, the R&D business unit’s quality assurance program. This includes overseeing and assisting with the Company’s training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation/ verification reports, analytical reports, and manufacturing records
  • Lead or assist to deliver monthly Quality Site Management Review Meetings as necessary
  • Along with the QA team, be responsible for the release or rejection of GMP materials for the R&D/Clinical business unit
  • Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function in R&D
  • Identify and lead operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas
  • Collaborate with appropriate cross-functional departments to create and implement global corporate standards
  • Partner with colleagues in other departments to increase the overall effectiveness of the Quality department and identify process improvements/ efficiencies
  • Assist in cultivating good customer relations that foster profitable new and repeat business for the site
  • Facilitate communication with customers and the site Quality department Ensure facility compliance with current good manufacturing practices and applicable regulatory guidelines for the R&D business unit

Required

  • Bachelor’s Degree in Life Sciences or related field
  • 8+ years of experience in the Pharmaceutical industry, with at least 5 of those years being experience in Quality
  • Experience in aseptic fill/ finish and sterility assurance programs
  • Experience in clinical quality assurance
  • Superior influential and negotiation skills
  • Solid knowledge in FDA and global regulations, especially the cGMP for the 21st century initiatives

Preferred

  • Leadership experiences – integrity, experience with operational excellence focus on strategy
  • The flexibility to adapt to changing circumstances and manage activities to meet the needs of the business while maintaining a focus on quality
  • Demonstrated ability to manage across departments to maximize productivity, reduce costs and increase profitability through leadership
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