Commercial Quality Sr. Manager - São Paulo, Brasil - Johnson And Johnson

Descrição

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Overall purpose of job:
Drive Commercial Quality operating model to deliver outcome-driven Quality solutions that will enhance customer and patient experience. Commercial Quality Sr.

Manager oversees NPI (New Product Introduction), Advance therapies portfolio lifecycle management, NBD (New Business Development), Digital Health Solutions, Product Life Cycle management, Product Quality Complaints, Suppliers Management and Patient Solutions Program quality and regulatory compliance processes deployment in Brazil.

The role will ensure risk approach assessment, development and deployment of strategies for business solutions, alignment and harmonization with Quality and Regulatory corporate policies and local regulations


Key Responsibilities:

• Develop and support direct reports.
• Act and foster others to work based on Our Credo.
• Foster novel, lean and inclusive Commercial Quality solutions for those processes under your responsibility acting as a Quality liaison for Commercial, Operational (Supply Chain and Deliver Ops) structures connected to the business: NPI (New Product Introduction), Advance Therapies & CVTs, NBD (New Business Development), Sales Excellence, PSP, Purchase Control, Supply Chain Demand Planing, Supply Chain Quality, Regulatory Affairs, as well as our internal organization in Global Quality;
• Lead Supplier Quality strategy at local and support regional projects and best practices.

supporting regional and local teams and active support to global CQ forum of supplier quality management including procedures, digital solutions to improve selection, qualification and monitoring of suppliers; * Ensure compliance management of GxP process, documents, metrics, among other quality elements, tools and systems around PSP, RRA and PQV by leading and partnering with other compliance and business areas to achieve the requirements of the J&J Quality standards and policies; * Responsible for the overall PQC management which includes process, metrics, procedures, among other elements associated to PQC, PV and Call Center; * Engage different levels and structures on regional areas to ensure cross-functional team alignment on an ongoing basis, being recognized as business enabler and functional area partner; * Build leadership in an independent workstream with exposure to global / regional and local senior leaders; * Translating and fitting for purpose the CQ standards taking into consideration local business needs and alternatives to ensure compliance to J&J policies and procedures; * Represent and support CQ Director to develop and built CQ road map and G&Os considering global, regional and commercial strategy, local needs as well as key drivers; * Foster efficient governance models, definition and tracking of G&Os and key initiatives in place; * Provide coaching, guidance and leadership for the Commercial Quality team under scope; * Ensure communication processes for CQ.

Launch Excellence, Advanced Therapies and New Business Development:

• The position will connect as required with the different stakeholders (Pharmacovigilance, Regulatory Affairs, Medical Affairs, Deliver, Supply Chain, Government Affairs, NBD, Commercial, Technology Quality) within the global, regional and local teams to evaluate processes simplification and efficiency, apply strategic quality compliance decisions on execution.
• Role will be responsible for creating, harmonize and deploy the necessary ways of working (governance and definition roles & responsibilities) to ensure successful and compliant launches & NBD projects according to Global Quality Standards and Regional harmonization documents.

Essential knowledge and skills:

• Bachelor/master's in pharmacy / Chemistry / Biosciences / Engineering / Operations Management (Business) or related subject 8-10 years' experience in Quality & Compliance functions in highly regulated products industries (Pharmaceutical, Medical Devices or Cosmetics).
• Advance therapies knowledge (technical and/or operational and/or commercial)
• Knowledge and understanding of various markets needs regarding quality and regulatory environment;
• Experience with business analytics, confident and effective facilitation of discussions, ability to intellectually challenge, influence and negotiate;
• Demonstrated ability to communicate effectively, specially listening;
• Strong problem solving and decision-making skills;
• Solid risk based approach experience;
• Strategic mindset to be seen as an enabler/ partner for Commercial as well as functional areas;
• Robust expertise on Quality Systems and Processes, Regulatory environment within a Pharmaceutical industry (preferred) environment (creation, implementation, alignment).
• Fluent in English
• Advanced Portuguese/Spanish Core competencies required for this role:
• Strong communication skills both written and verbal.
• Critical and analytical thinking ability.
• Proven communication, presentation, and influence skills.
• Excellent interpersonal skills.
• Strong problem solving and decision-making skills. Being part of Johnson & Johnson can change everything, including YOU Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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