Senior Manager, Swiss Responsible Person and GDP Quality Assurance

About this role

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.By submitting your application for employment, you confirm that you agree to the storing and processing of your personal data by Rhythm Pharmaceuticals as described in our Privacy Statement. EU residents, please see our privacy policy on data use.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.Senior Manager, Swiss Responsible Person and GDP Quality AssuranceZug, Zug, SwitzerlandFull TimeTech OpsExperiencedShareCompany OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. 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 OverviewRhythm is seeking an experienced Quality leader to serve as theResponsible Person (RP)for Switzerland under the Swissmedic Wholesale Distribution License (WDL). The RP is fully accountable for product quality and regulatory compliance under Art.

11 ff of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1) for all commercial distribution activities within the Swiss territory.In addition to Swiss RP duties, the role provides operational, technical, and compliance support to the global GDPoperations, ensuring alignment and consistency across GDP processes, records, electronic systems, and compliance activities across international markets.Responsibilities and DutiesSwiss Responsible Person  (RP) & Swissmedic Regulatory Compliance:Maintain an effective local QMS, overseeing authorized activities and ensuring accurate, inspection-ready, high-quality records.Act as the primary regulatory and technical contact person for Swissmedic, managing communications and hosting health authority inspections.Ensure non-conforming medicinal products, such as expired goods or those failing to meet specifications, are clearly labelled, segregated, quarantined, and not released to the market, and that packaging complies with current Swissmedic approvals.Decide on the final disposition of returned, rejected, recalled, or falsified products for the Swiss market.Effectively manage product quality complaints, inquiries, and temperature excursions in accordance with local regulations.Conduct regular self-inspections according to a set schedule, monitor GDP compliance, and implement corrective actions as needed.Approve test reports and technical documentation for finished medicinal products or returning saleable products.Ensure appropriate samples are taken and kept as retention samples in accordance with Swiss regulatory standards.Complete and document all mock or actual recalls accurately and within the specified regulatory time frame.Oversee that medicinal products in Switzerland are supplied only to customers and entities authorized to distribute or dispense them under GDP.Ensure suppliers, distributors, 3PLs, and subcontracted activities are approved and qualified.Ensure that initial and continuous GDP training programs are implemented and maintained for relevant personnel. Ensure Swiss-specific assessment and evaluation of APQRs are conducted in accordance with Swissmedic timelines.Conduct Annual Management Reviews for the Swiss establishment license.Manage deviations and changes appropriately and promptly notify Swissmedic of any major change according to Art. 41 of MPLO.Ensure that appropriate Corrective and Preventive Actions (CAPAs) are clearly defined as required and effectively managed throughout their implementation.Ensure potential quality and supply chain risks are thoroughly analyzed and managed effectively.Establish and maintain formal Deputy/Backup Responsible Person delegation procedures to guarantee continuous license oversight and coverage during absences.Global GDP Operations & Quality Systems SupportSupport global GDP operations by reviewing documents, preparing batch disposition and return paperwork, and coordinating approval processes within Veeva.Manage temperature excursions and distribution events ensuring all incidents are properly recorded, root causes investigated, and corrective actions are implemented in line with global GDP standards.Support GDP audits and self‑inspections, including management of records within Veeva eQMS and tracking audit remediation commitments.Support maintenance and authoring of global GDP procedures, work instructions, forms, and templates to ensure consistent execution across all Rhythm GDP markets.Contribute to global GDP change control, deviation, CAPA, and quality event administration, ensuring consistent documentation and follow‑up across regions.Coordinate and facilitate global GDP training activities.Collaborate cross-functionally with Supply Chain, Regulatory Affairs, and Commercial Teams to support international expansion and product launch readiness.Qualifications and SkillsUniversity degree in Pharmacy, Chemistry, Medicine, Biology, or related Life Sciences; must meet all Swissmedic statutory criteria under MPLO Art.

11/12 to be approved as Responsible Person (RP).8 +years of progressive Quality Assurance / GDP experience in the commercial pharmaceutical or biotech sector.Broad and deep knowledge of Swiss therapeutic products legislation and EU GDP guidelines.Excellent documentation, organisational, and administrative skillsProven experience in managing outsourced GDP activities, CMOs, and 3PL logistics partners in a virtual environmentDemonstrated experience with Electronic Quality Management Systems.Strong interpersonal and communication skills in English (written and verbal); professional working proficiency or fluency in German and/or French is strongly preferred for Swissmedic interactions.Proven ability to lead cross-functional investigations, risk assessments, and decision-making in a fast-paced, matrixed global biotech organization.More About RhythmWe 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 melanocortin-4 receptor (MC4R) pathway 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 AreWe are committed to advancing scientific understanding to improve patients’ livesWe are inspired to tackle tough challenges and have the courage to ask bold questionsWe are eager to learn and adaptWe believe collaboration and ownership are foundational for our successWe value the unique contribution each individual brings to furthering our missionInherent in our core values is the commitment to act ethically and with integrity in all we do.ShareApplyApply for this positionRequiredFirst NameLast NameEmail AddressPhoneAddressResumeWe've received your resume.

Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileAre you legally eligible to work in Switzerland?-- No answer --YesNoAre you currently a Swiss Responsible Person?-- No answer --YesNoDo you meet the qualifications to be a Swiss Responsible Person?-- No answer --YesNoHuman CheckSubmit Application