Role Overview
The Director of Quality Assurance (QA) will provide oversight and support for Savara’s Finished Goods (FG) operations and distribution in Europe, United Kingdom and other countries to ensure patient safety and compliance with European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and other applicable global health authority requirements as appropriate. This role, under the guidance of the Senior Director of Quality Assurance, will support the review and release processes, oversight of distribution activities, and product complaint management. In addition, this individual provides expertise to partners both internally and to our Contract Manufacturing Organizations (CMOs), supports the Qualified Person (QP),and partners to drive continuous process improvement and mitigation activities. The Director of QA will identify risks, resolve issues, and escalate matters as necessary to ensure product quality. This role is based in Copenhagen.
Core Responsibilities
- Reviews and approves manufacturing, testing, labeling/packaging, and other related documents for completeness and acceptability in a timely manner.
- Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements.
- Assures compliance to cGMPs through review and lot disposition of Finished Goods (FG).
- Works closely with the Qualified Peron to ensure 2-way communication and timely certification of batches.
- Supports the Product Complaint process, providing appropriate Quality oversight, resolution and maintaining metrics for commercial supply.
- Create and revise relevant Standard Operating Procedures (SOP) and/or Work Instructions (WI) related to GxP activities, with primary focus on cGMP regulations.
- Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DP/FP release and CAPAs.
- Assist in preparation and review of regulatory filings and safety data (e.g., Marketing Authorization, Annual Reports); ensuring compliance with regulatory procedures.
- Drive continuous improvement of the QA processes, identifying opportunities and leading them through implementation.
- Perform additional quality-related duties as assigned by Senior Director, Quality Assurance.
- Other duties as assigned.
Required Qualifications
- Bachelor or master’s degree in Biology, Chemistry, Engineering, or related fields.
- A minimum of seven (7) years of GxP leadership with a focus on Quality Assurance (QA) with substantial operational experience; cGMP expertise required.
- Demonstrated knowledge and thorough understanding of commercial manufacturing, product complaints, distribution quality, quality processes, EU, UK and ROW Health Authority regulations, and industry standards such as ICH, WHO and RX360 for the pharmaceutical industry.
- Continually evaluates and interprets regulatory standards and ICH guidelines to provide insight into current processes and recommends updates as appropriate.
- Extensive experience in a virtual manufacturing environment. Biologics technical understanding is required. Small molecule and combination products is preferred.
- Excellent verbal, written, and presentation communication skills, ability to collaborate with cross-functional teams and independently prioritize work, build relationships, and manage multiple projects while maintaining quality and advocating compliance.
- Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
- Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment.
- Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times.
- Ability to deal with ambiguity, and provide creative and pragmatic solutions to issues and risks.
- Experience interacting with global regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing preferred.
Work Schedule and Location
- This role is based in Copenhagen, Denmark.
- Occasional travel to the corporate office outside of Philadelphia, PA and global vendor/partner sites is required.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.
