QA Manager, CMC Development - Job ID: 1165

Join the QA Development Team in a leading and fast-growing biotech company

Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to supporting your personal development on our journey towards becoming a leading rare disease company.

Ascendis Pharma QA Development is currently expanding to support the increasing CMC development activities within the Endocrinology and Oncology pipelines.

You will work closely with the CMC Development team in Redwood City and the Development QA Team in Copenhagen to support ongoing responsibilities and defined goals by ensuring that activities are in compliance with Ascendis Pharma's Quality Management System. You will be responsible for ensuring that development activities are conducted in accordance with EU GMP and US GMP to support the different activities conducted on a global scale. You will be leading initiatives to ensure process quality consistency at all Ascendis Pharma sites and for ensuring a smooth quality transition for the CMO and CRO partners to Ascendis Pharma.

The key responsibilities are:

• Ensuring and developing GMP Compliance at the Ascendis Redwood City Site in tight collaboration with the Ascendis Copenhagen HQ.
• CMO responsibility regarding Compliance & Quality all over the world.
• Handling of CMO validations, deviations, Change controls, raw data review, etc.
• Ensure quality oversight of CMO-manufactured drug products.
• Apply global regulations, agency guidelines, and internal procedures to ensure compliance.
• Assist the CMC and regulatory departments in fillings (INDs, CTAs).
• Schedule, plan, and prepare CMO, CRO, and/or laboratory for audits (May also audit internal processes, submission documents, etc. in accordance with the audit plan or as requested).
• Communicate audit results to stakeholders.
• Assist with GMP inspection readiness activities for regulatory authority inspections and coordinate tracking of document requests, responses, and supporting documentation during inspections.
• Develop and implement GxP systems and procedures including SOPs, policies, forms, and tools.
• Identify and communicate quality or compliance risks and participate in the development of an appropriate plan to address risks.
• Ensure that documentation, procedures, and processes supporting development programs are maintained in compliance with company and industry standards and global regulations.
• Maintain working knowledge of current FDA, EU, and other global regulations and guidance governing; Good Manufacturing Practice (GMP), Pharmacovigilance (PV), and Good Laboratory Practice (GLP) activities.

Requirements

• Relevant Academic degree - preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like.
• At least 5 - 10 years of experience in Quality Assurance.
• A minimum of 2 years of experience working with CMOs and CROs.
• A minimum of 2 years of experience with process development and general manufacturing processes for Drug Products.
• A minimum of 2 years of experience with analytical development and general analytical testing for Drug Products.
• Strong quality mindset.
• Thorough knowledge of the drug development process (Phase I - Phase III).
• Proficient knowledge of worldwide GxP compliance regulations (EMA and FDA as a minimum).
• Thorough Knowledge within:
• Research and development practices.
• Scientific and quality terminology.
• Industry standards for quality assurance, quality management procedures, policies, and quality evaluation techniques.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law

You are proficient in English at a professional level, both written and spoken and you master MS Office.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in preparing Ascendis Pharma to become a pharmaceutical company with commercial production and will work with highly skilled and experienced colleagues.

Traveling: 20 - 30 days per year.

Estimated compensation: $145-160K/year DOE

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance