Sr. Manager QA Quality Management Systems

6 days ago

Boston, Massachusetts, United States Pharvaris Full time

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have real impact on people's lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you.

We are now seeking a highly motivated and experienced Sr Manager, QA Quality Management Systems to join and help drive our development and compliance efforts.

Location

This role is based in the US (East Coast). Pharvaris supports its staff to be home based and work virtually.

General description

The Sr Manager QA Quality Management Systems reports to the Director Quality Management Systems Lead and works with the cross functional teams and applies in-depth knowledge and experience in Quality Systems and Compliance to streamline and strengthen the QMS with an immediate goal to become inspection ready for the lead product at Pharvaris.

Responsibilities

  • Support the GMP Quality Management System (QMS) processes and help drive continuous improvement activities to adapt to the requirements according to Pharvaris' needs.
  • Collaborate cross functionally to administer and maintain the ACE electronic QMS (eQMS) system while ensuring compliance and efficiency.
  • Assist in the design, implementation, management, and improvement of the eQMS associated with GMP aspects of development such as change control, corrective and preventative actions (CAPAs), deviations, investigations, out of specification/out of trend investigations, vendor management, document control and training.
  • Responsible for QMS elements such as Document Management, Deviations, Change Control, CAPA, and Metrics.
  • Partner and facilitate coordination of change controls, deviations, CAPAs, and document workflows.
  • Support Quality Management in the development and implementation of training strategies and matrices to ensure personnel are appropriately trained to carry out their responsibilities.
  • Assist in the execution and the tracking of internal and external audits as needed.
  • Supports regulatory inspections or third-party audits.
  • Contributes to creation and continuous improvement of governance and procedural documents (e.g., quality manual, policies, and standard operating procedures.) Provides cross functional guidance on how to author, review, and approve procedures in the eQMS.
  • Assist in maintaining oversight of approved vendors and annual audit schedule.
  • Assist in the compilation of data to go into quarterly business management review presentations.
  • Works cross-functionally to establish and promote a healthy Quality culture throughout the organization.

Required Qualifications, working experience, competencies

  • BS/BA in a scientific, engineering discipline, or other related field (or equivalent level of training, education and experience) with at least 6 years' experience in pharmaceutical / biotech industry within Quality Assurance
  • Working knowledge of relevant US, EU, and global regulations and guidance (ICH, ISPE, etc)
  • Experience implementing and improving quality systems applications, such as Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and Electronic Quality Management Systems (eQMS)
  • Has a strong understanding of relevant regulatory and compliance framework, and is familiar with global regulations and internationally recognized standards (e.g., FDA, EU, PIC/S, ISO)
  • Excellent interpersonal and negotiation skills, using a team-oriented approach to problem solving complex issues backed by scientific rationale
  • Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations. English is company language.
  • Able to manage multiple projects and collaborate across various functional groups
  • Ability to thrive in a dynamic environment with high level of agility; a wide degree of creativity and strategic thinking is expected
  • Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results
  • Ability to multi-task and manage workload independently

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