OPPORTUNITY OVERVIEW

Rhythm is looking for a Sr. Manager QA who is eligible to become a Qualified Person (QP) in the EU and will play a key role in ensuring quality and regulation-based compliance during the manufacture and final batch release of Rhythm clinical and commercial products. He/she will be a key team member of the Technical Operations GMP and GDP QA group. His/her main activities include execution of GMP batch release and final batch certification of all commercial batches, ensuring appropriate level of quality oversight within the legal entity; supporting manufacturing and distribution from a quality and compliance perspective and generally enhancing and strengthening good manufacturing and distribution quality culture across the board.
The Sr. Manager QA/ QP will report to the Senior Director GMP & GDP QA, based in The Netherlands, while supporting and liaising with global functions at Rhythm.

Responsibilities and Duties

• The Rhythm QP has the responsibilities laid out in Article 51 EU Directive 2001/83/EC.
• Responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the EU, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
• The Rhythm QP has the primary responsibilities for the final QP certification/release of clinical and commercial drug product batches to the EU, UK and export countries.
• Has knowledge of the entire supply chain of the active substance and medicinal product up to the stage of certification.
• The Rhythm QP is permanently and continuously at the disposal of the Marketing Authorization Holder.
• Participates in investigations on deviations, customer complaints, and review of quality records and change controls related to manufacturing.
• Leads the initial and routine qualification and auditing process for Rhythm contract manufacturers and analytical laboratories.
• Provides technical advice on GMP-related business initiatives, risk assessments and risk mitigation plans.
• Liaise with suppliers and customers with respect to quality aspects in supporting existing business and new product introductions to CMO network.
• Manage the review and approval of CMO production and validation protocols required during standard operations and/or projects and technical transfers.
• To participate in managing/writing/approving Technical Quality Agreement for suppliers and contract manufacturing and testing facilities.
• Support the creation and revision of Artwork and material master data and safeguarding GMP/GDP information
• Create, review and approve relevant SOPs and work instructions relevant to GMP and GDP activities
• Support the development and maintenance of key Quality Performance Indicators for evaluating and improving overall Quality status and organizational quality culture
• To build an effective working relationship with global Rhythm functions and departments in order to achieve an acceptable quality level and provide guidance on how to execute their tasks and responsibilities in line with GMP requirements.
• Represent the company during health authority correspondences and routine inspections
• Master’s degree in pharmaceutical life sciences i.e. Pharmacy, Industrial Pharmacy, Biotechnology, Biopharmaceutics, and equivalent.
• Eligibility as a QP and fulfills the minimum conditions and qualifications set forth in the EU Article 49 EU Directive 2001/83/EC for medicinal products for human use.

Qualifications and Skills

• Master’s degree in pharmaceutical life sciences i.e. Pharmacy, Industrial Pharmacy, Biotechnology, Biopharmaceutics, and equivalent.
• Eligibility as a QP and fulfills the minimum conditions and qualifications set forth in the EU Article 49 EU Directive 2001/83/EC for medicinal products for human use.
• A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in manufacturing and distributing Clinical and Commercial products; experience in peptides is a plus
• Up-to-date knowledge of current FDA and European Guidelines on Good Manufacturing and Distribution Practices, as related to the Pharmaceutical Industry
• Experience in managing external partners and customers remotely
• Highly independent and with strong decision making capabilities

• Interpersonal communication and collaborative skills in dealing with a broad variety of cultures and teamsFluency in English is a must and another European language is a plus

• Rhythm operates in a hybrid work environment. This role is based out of our international office in Amsterdam. Candidates applying must be willing and able to be in the Amsterdam office in coordination with their department and business needs.
  More about Rhythm
  We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt

• The Rhythm QP has the responsibilities laid out in Article 51 EU Directive 2001/83/EC.
• Responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the EU, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
• The Rhythm QP has the primary responsibilities for the final QP certification/release of clinical and commercial drug product batches to the EU, UK and export countries.
• Has knowledge of the entire supply chain of the active substance and medicinal product up to the stage of certification.
• The Rhythm QP is permanently and continuously at the disposal of the Marketing Authorization Holder.
• Participates in investigations on deviations, customer complaints, and review of quality records and change controls related to manufacturing.
• Leads the initial and routine qualification and auditing process for Rhythm contract manufacturers and analytical laboratories.
• Provides technical advice on GMP-related business initiatives, risk assessments and risk mitigation plans.
• Liaise with suppliers and customers with respect to quality aspects in supporting existing business and new product introductions to CMO network.
• Manage the review and approval of CMO production and validation protocols required during standard operations and/or projects and technical transfers.
• To participate in managing/writing/approving Technical Quality Agreement for suppliers and contract manufacturing and testing facilities.
• Support the creation and revision of Artwork and material master data and safeguarding GMP/GDP information
• Create, review and approve relevant SOPs and work instructions relevant to GMP and GDP activities
• Support the development and maintenance of key Quality Performance Indicators for evaluating and improving overall Quality status and organizational quality culture
• To build an effective working relationship with global Rhythm functions and departments in order to achieve an acceptable quality level and provide guidance on how to execute their tasks and responsibilities in line with GMP requirements.
• Represent the company during health authority correspondences and routine inspections
• Master’s degree in pharmaceutical life sciences i.e. Pharmacy, Industrial Pharmacy, Biotechnology, Biopharmaceutics, and equivalent.
• Eligibility as a QP and fulfills the minimum conditions and qualifications set forth in the EU Article 49 EU Directive 2001/83/EC for medicinal products for human use