Head of QA

GRANITE BIO is a private biotechnology company located in Basel (Switzerland).
GRANITE BIO is supported by top-tier investors with ~$100M raised to date. Based on fundamental research conducted over the last two decades, GRANITE BIO's is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT-001, the lead asset, depletes inflammatory monocytes. It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic effect. The Phase 1b trial in patients with Ulcerative Colitis has just started. GRT-002 is an IL-3 neutralizing antibody that is thought to play an important role in type II inflammation.
Our company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. The successful candidate will be highly motivated and enthusiastic with a positive "can do" attitude, attention to details and innovation, strong organizational and communication skills.

RESPONSIBILITIES

The successful candidates is responsible for all aspect of quality assurance related to GLP, GMP, GCP in Granite Bio:

• Implement and maintain a comprehensive quality management system that aligns with regulatory requirements such as GMP, ICH GCP and industry standards. 
• Act as GMP Quality representative in collaborations with CDMOs and other stakeholders, covering quality assurance and quality control. 
• Lead interaction with established GCP QA third party vendor/consultant for GCP QA operations.
• Contribute to develop and maintain a suitable quality strategy and standards for Granite Bio, matching the needs of our growing development organization.
• Generate and/or maintain the essential quality documents (SOPs) and procedures and ensure contents are appropriate and compliant.
• Lead the development and implementation of training programs for quality management system requirements and ensure that all staff is appropriately trained.
• Act as QA representative in internal and external development teams (e.g. clinical trial team meetings, or interactions with CDMO and CRO), ensure compliance with procedures.
• Prepare and support vendor qualification including planning/execution of vendor audits.
• Provide guidance for the supply chain and release processes of clinical phase products.
• Conduct internal and external audits to ensure compliance with regulations, standards, and SOPs.
• Establish a system to evaluate, manage and maintain Qualified Supplier like CDMOs, CROs.
• Collaborate with senior management to identify and implement process improvements and quality initiatives that enhance the efficiency and effectiveness of clinical research and development operations.
• Represent the organization in regulatory inspections and audits.

WHO YOU ARE

• 15+ years of experience in Quality Assurance in GMP in Biopharmaceutical industry, additionally the successful candidate has strong hands-on knowledge in GCP standards.
• Sound understanding of biologics manufacturing and quality control for large molecules.
• Ability to develop practical and workable approaches for GxP quality assurance in a development focused start-up environment and the willingness to work strategically as well as operationally.
• Hands-on experience with internal and/or external audits at CDMOs and CROs.
• Sound understanding of achieving inspection readiness and experience in participating in inspections.
• Knowledge on electronic document or quality management systems.
• Team player spirit and a resourceful and fast learning mind-set.
• Good communication and interpersonal skills.
• Has worked in an international company/business environment before.
• Fluency in English is mandatory.

WHAT WE CURRENTLY OFFER

• Offices: Our well-equipped laboratories and offices are located at the Tech Park, a premier address for early-stage start-ups in Basel.
• Commuter Benefits: We support our employees tailored to their personal needs in commuting to work and offer parking facilities or a commuter contribution.
• Flexible Working: We support flexible working as appropriate.
• Christmas Closure: In addition to the 24 holidays per year, our offices/labs are closed between Christmas and New Year.
• Birthday Retreat: On top of that, your birthday is your personal holiday - our employees enjoy their birthday with a day off.
• Food: We like get-togethers during lunch time. Enjoy tasty, subsidised meals from our FELFEL food fridge.
• Coffee: Meet up with your colleagues and grab free coffee.
• Development: We support the individual development of our employees.
• Creativity: We offer an innovative and creative environment.
• People: We are an international and diverse team with talented and passionate people.
• Fun: From time-to-time we organise cool off-site summer and winter team events.

To apply, please send us this application form together with your CV and Cover letter.

---