CAREERS AT VYERA
Be a Part of the Vyera Vision
At Vyera, you can build a career that makes a valuable difference. We are proud to work with some of the most talented colleagues across the science, business and pharmaceutical industries. Together, we can vastly improve the lives of people who live with rare and serious diseases while driving a path forward in innovative medicinal advancements. Our team is seeking dedicated individuals to join our growing organization and contribute to finding solutions for some of our patients’ most critical challenges. Join us in implementing Vyera’s vision of patients living longer and healthier lives. Apply to one of our open positions today!
We Welcome Applications from All Qualified Candidates
We're looking for people who are passionate about identifying, creating and bringing to market therapies that can change the lives of underserved patients. We believe diversity is essential to creating a truly innovative and dynamic environment. To ensure that we support an atmosphere where innovative thinking can thrive, we look for applicants from a range of backgrounds and with a variety of work and life experiences.
If you’re interested in a career at Vyera, take a look at our current openings to find the best fit for your talents. Click any title to see a relevant job description and to submit your application for that position. If you have already submitted or saved an application, click My Account to retrieve it. For general applications, please send your resume to firstname.lastname@example.org.
Vyera Is an Equal Opportunity Employer
Vyera Pharmaceuticals, LLC is an Equal Opportunity employer. We are committed to the hiring, advancement and fair treatment of all individuals and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by federal, state, or local law. For more information about your rights as an applicant: EEO is the Law and EEO is the Law Supplement.
|Title:||Head of Quality Management|
|Department:||Research and Development|
|Number of Openings:||1|
VYERA PHARMACEUTICALS JOB DESCRIPTION
TITLE: Head of Quality Management
REPORTING TO: Senior VP, Head of Regulatory, Quality and Research and Development, and Country Head of Switzerland
LOCATION: Zug, Switzerland
SUMMARY OF POSITION:
The Head of Quality Management is a key position in the global quality framework for Vyera. This role ensures that Vyera maintains compliance with Quality Standards and its Quality System by being directly responsible for all aspects of the Quality Management System (QMS). A primary function will be to serve as the Responsible Person ("fachtechnisch verantwortliche Person") in accordance with all relevant provisions of Swiss law. This individual will be involved in any domestic and international audits/inspections that ensure compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards.
MAJOR ACTIVITIES AND RESPONSIBILITIES (may be directly responsible or through designee):
- Conducts activities required as Responsible Person (RP) in Switzerland as related to our business operations and ensure compliance with all relevant Swiss laws and regulations
- Review of documents and release process required for production of APIs and products for commercial distribution
- Quality audits of suppliers, vendors, manufacturers and distribution services utilized for commercial APIs and products
- Ensures that the company maintains compliance with current GMP, GDP, GLP, as applicable to Vyera directly, as well as to all service providers involved in the manufacturing, testing, packaging and distribution of APIs and products
- Hosting and preparation for health authority inspections at Vyera facilities
- Directs interaction with service providers during health authority inspections of their facilities as applies to Vyera commercial API/products
- Coordinating/preparing responses to health authorities when audit generates findings of deficiencies e.g. FDA Form 483, in conjunction with other relevant areas, e.g. Regulatory Affairs, CMC etc.
- Coordinating and directing activities involved in product recall, field alerts or product complaints
- Oversees the implementation and upgrade of Quality’s electronic documentation system which houses company policies and procedures as well as controlled documents
- Oversees the document control function for GxP and GxP-related documentation
- Oversees relevant Quality aspects of the Track and Trace system which is being implemented to comply with FDA’s DSCSA
- Ensures appropriate GxP SOPs and policies are created and implemented in accordance with applicable regulatory guidance
- Oversees activities associated with training on policies and SOPs
- Participates on special projects, as assigned
Education and/or Experience:
- Bachelor’s degree in a scientific or health-related field is required
- Master’s degree in a scientific or health- related field is preferred
- Minimum of ten years Quality experience in the biotechnology or pharmaceutical industries
- Thorough knowledge of Swiss legislation on Medicinal Products
- Thorough knowledge of local and international GxP regulations; knowledge of and experience with GDP requirements for Switzerland
- Knowledge of 21CFR part 11 requirements desired
- Must be proficient in MS Office Suite
Other Skills and Abilities:
- Excellent verbal and written communication and presentation skills in both English and German
- Excellent organizational skills and attention to detail
- Demonstrated leadership skills
- Ability to interact effectively with all levels of associates both internally and externally
- Ability to review documentation, processes and procedures as it relates to activities; to identify issues/problem areas; assess compliance; communicate findings to the Senior Leadership Team and/or Board of Directors
- Proven ability to manage projects, teams or personnel of significant scope and complexity, while meeting deliverables and timelines
Notice to Recruiters
Vyera's Human Resources Department manages the recruitment and employment process for the Company, and all candidates must be presented through this Department. If your agency wishes to establish a relationship with Vyera, you must work directly with the Human Resources Department. Contacting our hiring managers or employees directly is not appropriate. For more details, please email email@example.com.
For the protection of all parties involved, Vyera will only accept resumes from recruiters if an executed agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Vyera from recruiters do not constitute any type of relationship between the recruiter and Vyera and do not obligate the Company to pay fees should we hire from those resumes.