General Summary
As a Site Quality director, you will ensure compliance with Organon Policies and global industry standards, establish processes for regulatory trends, and guarantee product quality, efficacy, and safety. You will promote continuous improvement in quality processes, manage internal audits, provide training and guidance, and maintain effective data systems. Leading and empowering the quality team, you will drive operational excellence and manage the quality area budget to align with business needs. Your expertise in GMP, regulatory requirements, and quality management will be crucial in driving continuous improvement and innovation. Join us to make a significant impact on our commitment to delivering safe and effective products.
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This is a fully Onsite role with base in Xochimilco.
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Please note that this position does not offer relocation support. Candidates must be willing to work from the specified location and should not expect any assistance with moving or housing arrangements.
Responsibilities
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Ensure the development and implementation of quality assurance policies and procedures to guarantee compliance with Organon Policies and global industry standards. Establish processes for the periodic review and implementation of local and international regulatory trends in manufacturing, packaging, supply chain, and operations.
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Ensure that all products comply with the regulatory requirements of the markets where our products are distributed, including FDA guidelines. Guarantee the quality, efficacy, and safety of all products, and ensure that quality requirements for outsourced products and services are clearly defined through quality agreements.
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Establish a culture of continuous improvement to optimize quality processes, systems, and methods, improving productivity and service levels for internal and external customers.
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Ensure that the site has a robust internal audit process to manage inspections and ensure compliance with quality standards.
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Provide training and guidance, promoting teamwork and development. Establish technical and institutional training needs for personnel in quality assurance procedures and regulatory requirements.
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Establish and ensure effective data management systems, including physical and electronic documents that make up the quality system, with efficient technical documentation and annual product reviews.
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Lead and empower the quality organization, fostering employee development and engagement.
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Manage financial resources and the quality area budget, aligning with business needs and the priorities of each department.
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Acts as the Responsible Health Officer before COFEPRIS.
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Monitors and evaluates the effectiveness of quality systems and processes, optimizing and pursuing operational excellence.
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Promotes a culture of quality within the site and support areas, proactively ensuring that the site is always ready for regulatory inspections.
Academic Background / Experience / Knowledge / Skills:
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Completed University degree in Pharmacy, Chemistry, or a related field (Master’s degree In Pharmaceutical Sciences, Regulatory Affairs, Public Health, Quality Assurance or related is preferred).
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10+ years of experience in quality management within the pharmaceutical industry.
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5+ Years of experience leading a team of at least 5 direct reports.
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3+ Years of experience in Executive roles (Sr. Manager or Director Level)
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Strong Knowledge of pharmaceutical Normativity and Management Systems such as NOM-059-SSA1 and SHE.
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Extensive technical knowledge in Quality Assurance, Pharmaceutical Manufacturing, and the supply chain.
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Strong knowledge of GMP, GxP, and regulatory requirements.
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Fluency in Spanish and English, both oral and written.
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The ideal candidate will have proven leadership and team management skills, Excellent problem-solving and decision-making skills, Effective communication and interpersonal skills.
We Offer:
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Attractive base salary.
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Work-life balance initiatives.
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Workplace Perks.
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Direct Contract with Superior Benefits.
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Learning and development opportunities.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
