Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

We offer a fast-paced and collaborative work environment, with a competitive compensation and benefits package, including equity grants and the opportunity to participate in our employee stock purchase plan. We foster an environment that is supportive and fun – enabling us to bring our best each day toward achieving our goals. Working together, we’ll succeed.

We are centrally located in Boston’s Back Bay neighborhood, easily accessible by several modes of public transportation and walking distance to much of what the city has to offer.

We continue to grow, so if you don’t see anything here that currently fits your qualifications, please visit again to see what roles we have open.

Thank you for considering Rhythm.

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Note to agencies: Rhythm values our partnerships with recruiting firms and will only work with those who have an established relationship and signed contract. Authorization to work on a role and/or submit resumes will come from HR only, so please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Sr. Manager, Quality Assurance/Qualified Person

Amsterdam, Netherlands

Full Time

International

Experienced

Company Overview
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with rare genetic disorders of obesity. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

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

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 teams
Fluency 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

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