Sr/Director of Quality and Swiss Responsible Person (CH RP) (German: Fachtechnisch verantwortliche Person (FvP))

Sumitomo Pharma Switzerland GmbH (formerly Myovant Sciences GmbH) is a Sumitomo Pharma company and an affiliate of Sumitomo Pharma America (SMPA). We are part of an ecosystem that tackles unmet patient needs in the crucial fields of psychiatry and neurology, oncology, urology, women’s health, rare diseases, and cell and gene therapies. Our diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. For more information, visit Sumitomo-pharma.com.

Job Overview

The Swiss Sr/Director of Quality is a qualified Swiss Responsible Person (RP) and responsible for carrying out the direct technical supervision of the activities; in particular, ensuring the safety, quality, and compliant trading in medicinal products per Sumitomo Pharma Switzerland GmbH’s Establishment License (EL) in accordance with Articles 17-18 and 21-23 of the Medicinal Products Licensing Ordinance (MPLO/AMBV, as amended). The position holder performs activities that ensure the quality management system (QMS) of Sumitomo Pharma Switzerland GmbH is maintained in accordance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) requirements within the scope of the Swiss EL. This person reports directly (solid line) to the company’s overall Operational Vice President of GMP Quality with secondary (dotted line) reporting to the General Manager of Sumitomo Pharma Switzerland GmbH (SPS GmbH) and has a matrix relationship with the Sr. Director of PV Quality. In addition, the Swiss Sr/Director of Quality manages at least one Swiss Deputy Responsible Person (CH DRP) (German: Stellvertretende Fachtechnisch verantwortliche Person (St. FvP)).

Job Duties and Responsibilities

The Sr/Director (RP) will be responsible for ensuring the safety and quality of the drug products manufactured and distributed by Sumitomo Pharma Switzerland, GmbH, including all current and future territories where these drugs will be distributed by GmbH (e.g., US, Canada). The Sr/Director (RP) for Sumitomo Pharma Switzerland, GmbH conducts responsibilities as outlined in the RP directive.

The Sr/Director (RP) will be responsible for and perform the following:

• Ensuring operations are conducted within Sumitomo Pharma Switzerland GmbH’s Swiss EL for Wholesale covering issuance of manufacturing orders and Trading in Foreign Countries.
• Remaining current with regulatory developments impacting the Swiss EL and implementing any necessary changes in due time.
• Interacting with the Swiss Agency for Therapeutic Products (Swissmedic) for all quality-related topics, including hosting of Swissmedic inspections.
• Ensuring the QMS is compliant with Swiss legislation for all GxP-related activities, including maintenance of the site master file.
• Ensuring medicinal products are procured, manufactured, and supplied in accordance with the rules of GMP and GDP.
• Ensuring traceability of medicinal product batches, including assurance of appropriate serialization (as required per the receiving country) that connects each product unit to its origin, batch number and expiration date as an anti-falsification measure.
• Ensuring product traded abroad is delivered under approved, secure, and validated storage conditions, and any temperature excursions investigated.
• Participating in investigation of any allegations of security breaches (e.g., falsification, diversion) to ensure product subject to investigation is quarantined and Swissmedic notified, as needed.
• Evaluating the classification of quality defects and ensuring they are reported to Swissmedic according to Swiss requirements.
• Ensuring customers are suitably qualified for the receipt of SPS GmbH medicinal products.
• Attending routine Quality Team Meetings, CMO business reviews, and supplier audits appropriate to the products overseen as well as participate in SMPA Quality Management System (QMS) improvements and internal audits (participant in the internal/self-inspection and external audit programs).
• Escalating any supplier/vendor quality issues to internal vendor management (e.g., GMP/Product Quality), as appropriate.
• Reviewing the Annual Product Quality Review (APQR) as part of its approval process.
• Serve on the following Quality Committees with decision-making responsibility for GmbH commercial and clinical products (e.g., Gemtesa, Orgovyx, & Myfembree) manufactured and distributed by Sumitomo Pharma Switzerland, GmbH
• Serve on the Quality Steering Committee (group convened for escalation in the event of critical/significant quality issues arising from complaints, deviations, suspected fraud/falsified medicines, serious breach, audits, or other inputs), Material Review Board, Recall and Product Retrieval Committee.
• Annual Vendor Quality Risk Assessment and Supplier Quality Oversite for clinical and commercial product (e.g. Gemtesa, Orgovyx, & Myfembree) vendors
• Participating in Quality Management Review meetings for commercial (e.g. Gemtesa, Orgovyx, & Myfembree) Products
• Notifying the relevant pharmacovigilance function of awareness of any adverse event.
• Defining a training curriculum and responsibilities with respect to GxP for Swiss employees and contractors in cooperation with SMPA Global QA, and ensuring they are properly trained in relevant GxP requirements.
• Reviewing and approving change controls impacting activities conducted under the scope of the Swiss EL including those impacting subcontracted activities, as applicable.
• Ensuring Deputy RP(s) is available, qualified, and their qualification and training status is maintained.
• Approve Quality Agreements for Gemtesa, Orgovyx, & Myfembree (co-signed with Global Head of Quality or designee)
• Duties delegated to SMPA Inc. are outlined in an Intercompany Quality Agreement.

Key Core Competencies

• Quality leader and quality culture promoter within the global organization.
• Excellent verbal and written communication skills with fluency in both English and German.
• Ability to efficiently and effectively multi-task and collaborate across functions and geographies to follow through on activities to completion.
• High attention to detail, quality, and accuracy in performing job duties.
• Strategic and tactical in the planning and execution of quality initiatives and activities.
• Effectively train and manage direct report(s).
• Leader who values and demonstrates collaboration and teamwork.
• Classroom trainer of internal sites and departments on Swissmedic license requirements
• Advanced knowledge and use of computerized document and quality systems (e.g. Veeva, MasterControl).

Education and Experience

• 10-15 years’ experience required, (master’s degree preferred) with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.
• Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), therapeutic area (e.g. oncology, urology, regenerative medicine) and/or global distribution experience (e.g. Europe, North America, Asia) a plus.
• Experience with Advanced Therapy Medicinal Products (ATMP) licensing desired.
• Minimum of one year of experience as a Swiss RP (Requirements per I-SMI.TI.17) required; at least four years of experience is preferred.
• Meets the minimum requirements according to the Swiss Medicinal Products Licensing Ordinance (SR 812.212.1) as amended:
• The RP must have the necessary education and experience and be trustworthy. The position holder must also fulfill the requirements below:
• Holds a university diploma in a related field (e.g. pharmacy, bio/chemistry, or biology) as well as the experience necessary for the manufacture of ready-to-use medicinal products or holds other professional qualifications demonstrating sufficient knowledge and experience in the pharmaceutical sector.
• Education of higher studies (university or equivalent/higher technical institute) in natural sciences (or if applicable medicine or engineering) are valued.
• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.
• Advanced knowledge of medicinal product legislation and corresponding guidance to ensure oversight over the entire supply chain in line with applicable GDP rules.

The role requires flexibility to have regular calls in the late afternoon and evening with U.S. colleagues.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.