Quality Compliance Manager

2 giorni fa

Rho MI, Italia Tevapharm A tempo pieno

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, enabling TAPI to lead the industry based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Headquartered in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.

Job Purpose

Development and maintenance of quality programs, systems, processes, and procedures that establish and enforce compliance with policies and regulations, demonstrate that performances and quality conform to established standards and agency guidelines regarding compliance, and ensure best-practice quality assurance programs. Compliance assurance for quality control activities, with particular reference to documentation management and data integrity requirements fulfillment.

Main Responsibilities and Activities

In the Quality Department, we are looking for a brilliant profile reporting to the Site Quality Head with the following responsibilities and activities:

Quality Compliance:

  • Ensures compliance to site level procedures and demonstrates a solid understanding of Divisional policies by promptly addressing non-compliance issues as appropriate.
  • In collaboration with the Site Quality Head and the Qualified Person, reviews regulatory and quality compliance requirements, performs gap assessments, and establishes or improves SOPs covering all areas of applicability, developing and monitoring corrective action plans where needed.
  • Ensures local SOPs are aligned with DPs and cGMP guidelines. Supports the implementation of training for site staff on the implementation of DPs.
  • Supports the Site Quality Head (acting as backup, if necessary) for the development and implementation of Notifications to Management (NTMs), Global Notifications to Management (GNTMs), and participates in the escalation process through completion and closure.
  • Routinely collaborates with the global quality and compliance organization on the implementation of compliance initiatives.
  • Collaborates with the Regulatory Affairs function, with SQH and with the Qualified Person, to ensure conformity, completeness, and correspondence of the regulatory documentation.

Inspection Management:

  • Supports the management of Regulatory Authority, performs internal (self-inspection) and manages external compliance audits (including customers’ audits and GRA audits), taking care of communication, tracking, and resolution of observations (management of CAPA Plans related to observations).
  • In collaboration with the Site Quality Head and the Qualified Person, reports and manages performance of internal compliance audits including communication, tracking, and resolution of observations.

Inspection Readiness:

  • Assesses regulatory compliance status of the site with implementation of CAPAs to assure compliance.
  • Supports the Site Quality Head in reviewing observations from other TEVA sites and implementation of CAPAs as appropriate.
  • Verifies online compliance by coordinating random shop-floor rounds including all departments (Quality Walk Around).

Compliance for Quality Control:

  • Coordinates monitoring and/or reviewing/revising and implementing items required by Pharmacopoeias Compendial Updates.
  • Supports QC Manager in suitability and equivalency studies reports documentation.
  • Reviews/audits data; routine or periodical review of audit trails.

General Responsibilities:

  • Behaves according to company Ethical Code and company values.
  • Collaborates with Site Quality Head, QP, and Quality Assurance Manager to identify and implement continuous improvement opportunities.
  • Assists the Qualified Person of the site and collaborates with the QP in the performance of the function (DL. 219/06 art. 52 paragraph 10 and art. 64 paragraph 3).

Safety Responsibility:

“Preposto per la sicurezza” according to the Italian Law D.lgs 81/2008: Person who, in accordance to professional skills and function, supervises the work and ensures the implementation of the directives received, monitoring the successful execution by workers and exercising a functional power.

Requirements

  • At least 5 years of experience in quality management, preferably in Compliance.
  • Scientific Degree (Chemical and/or CTF), preferably a master's in Regulatory.
  • Good knowledge of computer systems.
  • Good knowledge of Italian and English languages.
  • Preferably: appointment by AIFA as Qualified Person.
  • Pharmaceutical industry experience.

What We Offer?

We try to take care of our employees, offering them small and large benefits. By way of example:

  • Canteen
  • Working flexibility for caregivers and parents
  • Coffee Key
  • Recognition Program
  • Welfare Platform
  • Health agreement with medical centers of excellence
  • Flexible working environment (2 days home office per week)
  • Highly inclusive and multicultural working environment
  • Continuous learning and development programs (with full access to Linkedin Learning)

Type of contract: long term contract.

Location and Working Program

Rho (MI), from Monday to Friday.

Teva's Commitment to Equal Opportunities

Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity, gender expression, protected categories, or any other legally recognized status that is entitled to protection under applicable laws.

#J-18808-Ljbffr

  • Quality Compliance Manager

    4 giorni fa

    Rho, Italia Teva Pharmaceuticals A tempo pieno

    Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products.We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies.We are proud of our reliable history in the generic API industry dating back over 80 years,...

  • Quality Compliance Manager

    22 ore fa

    Rho, Italia Tevapharm A tempo pieno

    TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the...

  • Quality Compliance Manager

    32 minuti fa

    Rho, Italia Tevapharm A tempo pieno

    TAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies.We are proud of our reliable history in the generic API industry dating back over 80 years, and the...

  • Quality Compliance Manager

    3 giorni fa

    Rho, Italia Tevapharm A tempo pieno

    TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the...

  • Quality Compliance Manager

    2 giorni fa

    Rho, Italia Teva Pharmaceutical Industries A tempo pieno

    Who we areTAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80...

  • Quality Compliance Manager

    22 ore fa

    Rho, Italia Tevapharm A tempo pieno

    TAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies.We are proud of our reliable history in the generic API industry dating back over 80 years, and the...

  • Quality Compliance Manager

    5 giorni fa

    Rho, Italia Teva Pharmaceuticals A tempo pieno

    Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80...

  • Senior Quality Compliance Manager

    1 mese fa

    Rho, Lombardia, Italia Teva Pharmaceuticals A tempo pieno

    About the RoleWe are seeking a highly skilled Senior Quality Compliance Manager to join our team at Teva Pharmaceuticals. As a key member of our Quality Assurance department, you will be responsible for ensuring that our manufacturing sites and R&D centers maintain a robust Quality Compliance System, guaranteeing compliance with regulatory requirements and...

  • Quality Compliance Director

    3 settimane fa

    Rho, Lombardia, Italia Teva Pharmaceuticals A tempo pieno

    Job OverviewThe ideal candidate for this position will be responsible for ensuring that TAPI manufacturing sites and R&D centers maintain a Quality Compliance System, guaranteeing compliance of activities, quality risk management, escalation of risks, and continuous improvement.Key ResponsibilitiesLead the implementation, maintenance, change process, and...

  • Senior Quality Compliance Specialist

    1 mese fa

    Rho, Lombardia, Italia Teva Pharmaceutical Industries A tempo pieno

    About the RoleWe are seeking an experienced Senior Quality Compliance Specialist to join our team at Teva Pharmaceutical Industries. As a key member of our Quality Compliance department, you will be responsible for ensuring the implementation and maintenance of a quality compliance system across our manufacturing sites and R&D centers. This will involve...

  • Associate Director Quality and Compliance

    3 settimane fa

    Rho (MI), Italia Tevapharm A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Job Id: 58364 TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we support 80% of top 50 global pharmaceutical companies. Our reliable history...

  • Associate Director Quality and Compliance

    3 settimane fa

    Rho (MI), Italia Teva Pharmaceuticals A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Company: Teva Pharmaceuticals Job Id: 58364 Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier...

  • Associate Director Quality And Compliance Lead

    3 settimane fa

    Rho, Lombardia, Italia Tevapharm A tempo pieno

    Job SummaryTevapharm seeks a highly experienced Associate Director Quality And Compliance to lead the development and implementation of a Quality Compliance System across its manufacturing sites and R&D centers. The successful candidate will have a proven track record in ensuring compliance with quality regulations and standards, as well as excellent...

  • Senior Director of Quality and Compliance

    1 mese fa

    Rho, Lombardia, Italia Tevapharm A tempo pieno

    Senior Director of Quality and ComplianceTAPI is a leading international supplier of active pharmaceutical ingredients (APIs) with a broad portfolio of over 350 API products. Our reliable history in the generic API industry dates back over 80 years, and we are considered one of the most trusted API suppliers. Our employees are at the core of our success,...

  • Associate Director Quality And Compliance

    1 mese fa

    Rho, Italia Teva Pharmaceuticals A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Company: Teva Pharmaceuticals Job Id: 58364 Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs,...

  • Associate Director Quality And Compliance

    1 mese fa

    Rho, Italia Tevapharm A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Job Id: 58364 TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we support 80% of top 50 global pharmaceutical companies. Our reliable history in the...

  • Associate Director Quality And Compliance

    3 settimane fa

    Rho, Italia Tevapharm A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Job Id: 58364 TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we support 80% of top 50 global pharmaceutical companies. Our reliable history in...

  • Associate Director Quality And Compliance

    2 mesi fa

    Rho, Italia Tevapharm A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date:  Sep 18, 2024 Location: Rho, Italy, 0000 Job Id:  58364 TAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products, we support 80% of top 50 global pharmaceutical companies.Our reliable history in...

  • Associate Director Quality And Compliance

    2 mesi fa

    Rho, Italia Tevapharm A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date:  Sep 18, 2024 Location: Rho, Italy, 0000 Job Id:  58364 TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we support 80% of top 50 global pharmaceutical companies. Our reliable history...

  • Associate Director Quality And Compliance

    2 mesi fa

    Rho, Italia Teva Pharmaceuticals A tempo pieno

    Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Company: Teva Pharmaceuticals Job Id: 58364 Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products.We are the go-to global supplier for APIs,...