Beigene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
please submit all resumes/cv's in english for consideration
location : mexico city/hybrid (this is hybrid role requiring 2 - 3 days per week onsite in office in mexico city)
language requirement : spanish and english required.
required experience : pharmaceutical/biotech industry
director, quality - mexico & latam cluster
general description:
the position will report to the senior director, head of quality, new markets. The director, mexico & cluster quality lead, new markets, will provide gmp/gdp expertise in the assigned region and supervise the affiliate setup in mexico and assigned region, commercial launch, post marketing quality activities (complaint, recall), distribution of imps and commercial products within assigned region for beigene (mexico and latam region, approximately 15 countries excluding brazil) and ensure the compliant affiliate setup, structure, interdependencies and supply with medicinal products and quality oversight of all distributors in the assigned region. The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory expectations and applicable quality standards.
essential functions:
* ensure that the affiliate quality management system of the mexican affiliate and the support the affiliates of the assigned territory to comply with relevant national and international guidelines and internal policies/global standards/sops.
* collaborates with distributors in the assigned territory and ensures their timely onboarding and qualification.
* act as single point of contact for distributors in the assigned territory.
* manages quality agreements, deviations, temperature excursions, change controls and capas for their assigned territory.
* assess and revise, as needed, sops and identify opportunities to streamline systems and processes. Create and maintain required documents and records in the qms system.
* actively contribute to establish and review global quality standards to ensure compliance with local law requirements.
* point of quality contact for all operational quality topics for commercial and investigational medicinal products for mexico and latam region (beside brazil).
* in country/region product disposition as necessary and collaborate for batch disposition of finished products with responsible persons/qualified persons as required.
* direct responsibility for mexico qms and batch releases; acting as the responsible person for mexico.
* oversee product complaint handling in new markets.
* collaborate with commercial, supply chain, affiliate management, regulatory, legal, and any additional departments required for launch setup.
* ensure that all quality processes are compliant, sustainable and meet health authorities expectations.
* participate in due diligence activities.
* support internal audit and health authority inspections.
* support functions and smes to maintain and improve the inspection readiness process/mock audits.
* advise and support agreements (e.g. Quality distribution, service, master, collaboration) regarding content, implementation, review and updates.
* support regulatory filings, as needed.
minimum requirements – education and experience:
* master degree in science or combination of education and equivalent work experience with a minimum of 7 years’ pharmaceutical or biotechnology industry experience.
* or
* bachelors degree in science or combination of education and equivalent work experience with a minimum of 10 years’ pharmaceutical or biotechnology industry experience.
* a minimum of 7 years’ quality experience in the mexican market.
other qualifications:
* extensive gmp and gdp experience in a quality and manufacturing function.
* knowledge of setting up affiliates in mexico and in other latam region countries.
* worked in commercial environment, technical development and clinical environment experience is an asset as well as regional experience in latam region.
* in-depth knowledge of gmps and gdps.
* in-depth knowledge of mexican quality regulations.
* in-depth knowledge of quality principles, concepts, industry practices and standards.
* in-depth knowledge of cofepris health authority requirements.
* working knowledge and experience with local and regional pharmaceutical regulations and experience in working with local health authority: cofepris. Experience with other health authorities is an asset like anmat in argentina, the ministry of health and social protection in colombia, ministerio de salud de chile.
* fluent spanish language skills is a prerequisite for this position.
* excellent verbal, written and interpersonal communication skills.
* ability to work independently with scientific/technical personnel.
* experience with regulatory compliance inspections.
* apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.
* must possess strong presentation skills to speak effectively before groups; ability to respond.
* excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
* strong project management skill set.
supervisory responsibilities: mexico quality affiliate and selected latam countries
travel:
* may travel approximately 25 %
* ability to work on a computer for extended periods of time.
computer skills:
* pc literate with ms office skills (project plan, powerpoint, outlook, word, excel, visio).
* veeva vault quality docs; veeva vault quality suite; veeva submissions; sap.
* ul compliancewire; ul learnshare.
beigene global competencies
when we exhibit our values of patients first, collaborative spirit, bold ingenuity and driving excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
* fosters teamwork.
* provides and solicits honest and actionable feedback.
* self-awareness.
* acts inclusively.
* demonstrates initiative.
* entrepreneurial mindset.
* continuous learning.
* embraces change.
* results-oriented.
* analytical thinking/data analysis.
* financial excellence.
* communicates with clarity.
we are proud to be an equal opportunity employer and we value diversity. Beigene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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