Quality & compliance manager page is loaded
quality & compliance manager
apply locations: ocoyoacac
time type: full time
posted on: posted 8 days ago
time left to apply: end date: june 13, 2025 (12 days left to apply)
position: site quality head
location: mx / toluca ocoyoacac / cdmx santa fé
type: indeterminate
about the job
opella, the consumer healthcare division of sanofi, is the third-largest player worldwide in the otc and vms market.
we believe strongly in the power of self-care and its role in creating a healthier society and planet.
our mission is to make personal care simple, always consumer-led, with science at our core.
with a portfolio of over 100 trusted brands, including high-growth global and local competitors like allegra, dulcolax, and buscopan, we aim to help over 500 million consumers worldwide take control of their health.
this mission is powered by a team of 11,000 people, 13 top-tier manufacturing sites, and 4 specialized science and innovation centers.
we are also proud to be the first major fast-growing healthcare company to achieve b corp certification.
join us in our mission. Health. In your hands.
purpose of the role
ensure that products manufactured and distributed by sanofi aventis mexico comply with good manufacturing practices, good documentation practices, quality directives, and hse requirements, meeting national and international regulatory standards and global quality directives, mitigating risks related to product quality, safety, and efficacy; proactively solving problems, proposing continuous improvements, and being a strategic asset and competitive edge.
responsibilities
* verify compliance with good manufacturing practices (gmp) and good documentation practices (gdp) at the site, ensuring product compliance with registration requirements, notifying health authorities or relevant regulatory entities when necessary, regarding market effects and adverse events, in accordance with directives and regulatory requirements.
* guarantee adherence to quality directives and current regulations, maintaining control to ensure site performance and quality indicators are met.
* document, investigate, monitor trends, review, and conclude non-conformities and complaints, identifying impacts/risk aspects related to hse and gmp, aiming to minimize occurrences following internal procedures.
* participate in special site projects, evaluate new critical equipment or systems, approve or reject components and materials in process, ensuring compliance with standard operating procedures (sops) related to quality.
* work with site operations to identify risks and improvement opportunities in the quality system, monitoring corrective and preventive actions to meet deadlines.
* promote a quality culture aligned with policies, leadership practices, diversity, inclusion, and lead competencies; lead by example, motivate the team, and facilitate resources for initiatives.
* identify, evaluate, and control impacts, aspects, and risks related to hse, gmp, and storage and distribution practices, setting improvement standards, involving the team in activities, processes, and projects, ensuring product quality and safety.
* handle inspections from national and international regulatory bodies and collaborate with cofepris, ensuring compliance for gmp certification and product release; conduct joint inspections, notify relevant authorities of plant or product risks, and manage documentation for regulatory filings.
* authorize control documents, approve master documents based on the quality management system, ensuring activities related to manufacturing, import, and export comply with gmp, gdp, registration files, and regulatory requirements.
indicators
* key quality performance indicators (capa, deviations, complaints).
* compliance with the quality program.
* compliance with site training programs.
* number of audit observations.
* import avs.
* number of projects on schedule.
requirements
previous experience
minimum 10 years in the pharmaceutical industry as a quality manager, quality director, responsible sanitary, or regulatory affairs manager.
experience focused on gmp, knowledge of bpf, regulatory procedures, and manufacturing processes to ensure compliance with national, international, and corporate regulations.
education
degree in pharmaceutical chemistry, biotechnology engineering, industrial pharmacy, chemical engineering, biochemical engineering, or related field.
essential knowledge
indispensable knowledge of the pharmaceutical industry, including national regulations (nom-059, nom-072, nom-073, pharmacopoeia), regulatory procedures with cofepris, and international guidelines (fda, emea).
leadership skills, regulatory knowledge, and a willingness to work on-site.
additional knowledge
good manufacturing practices, storage, and distribution practices, quality systems, documentation, and continuous improvement.
languages
advanced conversational english (capable of conducting business conversations).
why choose us?
· bring science miracles to life
· discover opportunities to grow your talent and advance your career, including international transfers
· enjoy a well-designed rewards package recognizing your contribution and amplifying your impact.
at opella, we provide equal opportunities regardless of race, color, ancestry, religion, sex, country of origin, sexual orientation, age, nationality, marital status, disability, or gender identity.
join us on our mission. Health. In your hands.
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