Job Description
About the Role:
Location: Baar, Switzerland
* In this role, you will serve as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), according to the Swiss Medicinal Products Licensing Ordinance (MPLO), SR 812.212.1, Articles 12, 13, 17, and 18, and the Swissmedic Technical Interpretation I-SMI.TI.17, within Biogen Switzerland AG (Swiss Affiliate).
* You will oversee quality assurance and support GxP activities at Biogen Affiliates and Distribution partners to ensure product quality all the way to the patient.
What You'll Do:
As the Deputy RP/FvP for Biogen Switzerland AG:
* You will have the authority to issue directives and take decisions with regards to your responsibilities, independently of Biogen Management and the Swiss Affiliate Leadership Team.
* You will ensure Quality Assurance related compliance with all National and International Regulations (e.g. MPLO, Cantonal Laws and Regulations, etc.) and internal regulations, focusing on the management of authorized activities, accuracy, and quality of records.
* You will ensure that all medicinal products are handled appropriately, particularly concerning the monitoring of product specifications (including Certificates of Compliance), testing instructions, storage conditions, expiry dates, and quality standards.
Your Responsibilities:
* You will decide and perform independently on the final release of batches to the Swiss market, according to local legislation.
* You will manage, report, and document product returns, including decision-making on reintegration to saleable stock.
* You will decide independently from Biogen Management and Swiss Affiliate Leadership Team on the disposition of rejected, recalled, falsified, and expired products.
* You will manage Product Quality Review (PQR/AQP) Assessments as per applicable SOPs and local law.
* You will ensure Inspection readiness of the applicable Operational License activities, e.g. import and wholesale activities.
* You will ensure timely renewal and update, if applicable, of Operational Licenses per Swissmedic License Application Process (min 6 months before expiry of license).
* You will be knowledgeable on GMP/GDP and changing Regulatory requirements and ensure appropriateness of licenses and distribution models to distribute medicinal products.
* You will ensure that suppliers and customers are approved in coordination with responsible departments.
* You will approve any sub-contracted activities that may have an impact on GMP/GDP regulations and be responsible for qualification and monitoring of such activities.
* You will develop and maintain local Quality Agreements.
* You will ensure that any additional requirements imposed on certain products by local Regulatory Bodies are adhered to.
* You will develop and maintain local procedures in alignment with local regulations and Global QMS.
* You will manage locally initiated and continuous training programs, including GxP training.
* You will oversee and approve local quality records (deviations, CAPAs, and Change Controls) and support as needed other quality-related tasks (Audit Module, Technical Product Complaints, Planned Exceptions).
* You will host local Health Authority inspections and Internal Affiliate Audits, including readiness and follow-up before, during, and after the inspection/audits. You will coordinate related follow-ups and CAPA development and implementation.
* You will lead, develop, and coordinate local Self-Inspection programs as per schedule, including risk assessment, and lead related follow-ups and CAPA development and implementation.
* You will review and evaluate internal audit reports, including CAPAs, of Manufacturers, CMOs, CROs, and Service Providers involved in the manufacturing, distribution, and storage of medicinal products intended for the Swiss market. You will request additional CAPAs if deemed necessary to comply with GMP/GDP Regulations and local registration requirements.
* You will ensure Technical Product Complaints (TPCs) are handled as per local and Global procedures and support TPC-related investigations and follow-ups, as necessary.
* You will ensure that customer complaints are addressed appropriately and dealt effectively.
* You will execute recalls in collaboration with local and global Recall Committees upon approval by Swissmedic. You will act as the local coordinator of a recall to be performed on the Swiss territory, including Liechtenstein. You will compile the local recall report upon closure of the recall by Swissmedic. You will follow-up on additional requests by Swissmedic after closure of the recall (e.g. CAPA implementation).
* You will manage temperature excursion assessments and finally decide on the usability of affected products.
* You will cooperate with all necessary departments to ensure that communication to Health Authorities is appropriate, coordinated, and approved.
As Manager, Quality Assurance:
* You will ensure that each Affiliate site maintains compliance to the required regulations in order to maintain appropriate licenses for distribution (e.g. but not limited to: GMP, WDA, MIA, ISO).
* You will coordinate activities to establish Affiliate-applicable licenses and liaise with all functional areas to meet license requirements (e.g. but not limited to: Compliance, R&D, Commercial, Legal).
* You will foster Quality understanding at Affiliate management by providing QA operational support, guidance, and supervision in Affiliate markets.
* You will manage Quality Systems for Affiliates to ensure all Biogen and applicable GxP regulations are met.
* You will ensure Affiliate QMS complies to Biogen Global QMS.
* You will ensure Biogen Global QMS is aligned and appropriate with Affiliates' requirements.
* You will manage Quality Management Review process for Affiliates.
* You will oversee appropriate Affiliate GxP vendor management program.
* You will support Affiliate audits and Health Authority Inspections with readiness/coordination/follow up.
* You will support Audits to Distribution partners.
* You will support drafting and review of Affiliate's GxP-related documents.
* You will oversee and approve local quality records (deviations, Planned Exceptions, CAPAs, Audit Module, and Change Controls).
* You will support temperature excursion assessments to external customers.
* You will approve exceptional in-country repackaging activities.
* You will develop, establish, and maintain Quality Agreements with external partners.
* You will assess regulatory environment to ascertain GxP requirements which may impact supply chain.
* You will ensure continuous supply of product and support product launches.
* You will support Distribution Model changes and product serialization.
* You will support coordination of the Recall process and recall activities as defined by the Recall Committee. You will monitor market activities and distributed product issues, and escalate immediately issues to the appropriate responsible (DMRB or Product Security).
* You will minimize out-of-stock situations in coordination with other functions.
You Are:
You are a highly skilled professional with a strong background in pharmaceutical sciences and Quality Assurance. You possess excellent analytical and problem-solving skills, with a proven track record of managing complex projects and teams. Your expertise in GMP/GDP regulations and experience working with international organizations make you an ideal candidate for this role.
Qualifications:
* Higher education in pharmaceutical or natural sciences, minimum Master's Level, preferably PhD or Pharmacist.
* Swissmedic Technical Interpretation I-SMI.TI.17.
* At least 5 years' experience in pharmaceutical or related industry in the field of QA/RA.
* Track record in the field of QA including registrations, audits & inspections.
* Fluent in English and German (speaking & writing).
* Willingness to continuously learn.
* Good knowledge of Biogen procedural documents, International Guidelines such as ICH/GCP, etc.
* Good understanding of regulations in GMP and GDP, good knowledge of certification processes.
* Good project management skills.
* Good knowledge of PC (Word, Excel, PowerPoint) and special applications.