Pieris Pharmaceuticals (Nasdaq: PIRS) is a publicly-traded, clinical-stage biotechnology company with operations in Germany and the United States. Pieris specializes in the discovery and development of Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.To strengthen our team, we are looking for an experienced:
Head of Quality Assurance (m/f/d)The Head of Quality Assurance will be responsible for all aspects of the quality function within Pieris, including leading a quality strategy and culture, development and implementation of a quality management system (QMS) to ensure GMP, GLP and GCP compliance for the Company’s IND-enabling activities and clinical-stage programs and associated CDMOs, CROs and other vendors. The position calls for high-level and long-term strategic planning as well as hands-on engagement with quality assurance activities at a fast-paced and growing organization.
- Provide senior leadership with regular updates regarding state of compliance, and risks including proposal of mitigation strategies.
- Oversee the phase-appropriate implementation, management and enhancement of the Pieris QMS. Identify and lead continuous improvement initiatives and help build a culture of continuous improvement and excellence.
- Review and approve documentation required by the QMS, including but not limited to the following: standard operating procedures (SOPs), master batch records, operational standards, validation protocols and reports, as required.
- Review and approve quality system related documentation, including but not limited to the following: change controls, deviations, complaints, out-of-specification (OOS) results, etc.
- Oversee and ensure a robust supplier quality management program which includes the scheduling, management and execution of supplier audits, ensuring quality agreements are in place (including the review, negotiation and approval of such agreements), evaluation of trends, and recommending appropriate corrective actions and continuous improvements.
- Lead inspection readiness activities.
- Host audits and inspections as necessary, and respond to observations from regulatory inspections.
- Support in quality aspects of regulatory filings
- Oversee and manage all GMP product review and final disposition.
- Ensure that validation and revalidation activities are appropriate and complete.
- Ensure that analytical methods are appropriately validated and that appropriate specifications are established.
- Implement and maintain the quality system to ensure clinical trials are conducted in compliance with the protocol, cGCP, and the applicable regulatory requirement(s).
- Ensure that controls are applied to each stage of data handling to ensure clinical data integrity and appropriate collection, storage, analysis and distribution of such data.
- Support management and triage of CRO related activities that support clinical trials as needed.
- Ensure that all facilities, equipment, personnel, methods, and records are in conformance with GLP regulations under which non-clinical studies are conducted.
- Experience with IND-enabling GLP studies and animal studies.
- Bachelor’s degree in science, pharmacy or a similar field along with post-graduate studies, as appropriate
- A minimum of 10 years’ experience in quality assurance within the biopharmaceutical industry or a related field, including at least 5 years’ experience in a leadership role.
- Demonstrated success in the development, implementation, and continuous improvement of systems, procedures, and processes to maintain GxP compliance.
- Excellent understanding of quality principles, industry practices, and standards with demonstrated ability to apply these to GxP operations.
- Demonstrated knowledge of GMP, GLP and GCP and regulatory requirements for manufacturing required. Experience of sterility manufacturing for drug substance and/or drug products for pharmaceutical products and processes strongly desirable.
- Thorough knowledge of global regulations and thorough quality system experience (deviations, CAPAs, change control, validation concepts for pharmaceutical drug substance and drug product manufacturing).
- Experience with EU and US requirements including early phase application of the regulations to support a fast-paced environment.
- Vendor management and audit experience for a variety of small to mid-sized companies to support CMO, CTL, and CRO Qualification.
- Understanding of ICH guidelines and application of Risk based methodologies across the different phases of pharmaceutical development.
We are a fast-growing biotechnology company with approximately 130 employees at our sites in Freising (Greater Munich Area) and Boston (USA). We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of individual and company-wide goals. In addition, we offer each employee the opportunity to participate in a stock savings plan and a stock option program that allows employees to benefit directly from the company's success.
Numerous social benefits such as additional employer-financed company health insurance, free drinks, fruit baskets etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in our new company building in Hallbergmoos (from January 2020) round off our overall package. Creative employee events take place several times a year, as team spirit is essential for us. The joint creation of an innovative and participative corporate culture is an important concern for us.