Job Description

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Global QA DD Manager 100% (f/m/d)

Zurich / Oerlikon, International/Corporate

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our global QA team in Zurich as

Global QA DD Manager 100 % (f/m/d)

Job Purpose:

The role of the Global QA Manager Due Diligence oversees the Due Diligence (DD) Lead for assigned global product acquisition and in-licensing deals and support of Due Diligence for local products. Additionally, supports all onboarding and ongoing DD and compliance reviews are being performed on a timely and accurately manner, to maintain a strong compliance program and at the same time high levels of internal customer satisfaction. Candidate should be comfortable working in a fast-paced, dynamic environment and embrace change.

Major Accountabilities:

  • Support effective management of quality DD process and activities related to Acino global product acquisition and in-licensing deals
  • Plan and lead DD audits for new deals through on site audits/ -remote audits. Compile the DD audit reports/elevation slides to summarize the risks associated with potential partners and to ensure timely communication with cross functional teams/project leads
  • Support any assigned company acquisition activities providing support to the QA Lead and ensuring key quality risks and mitigation measures are identified, protecting Acino and patient
  • Reviewing any Quality Questionnaires returned by the Suppliers and resolve any issues
  • All activities required to plan, prepare for, conduct, report and close the assigned DD audits
  • Ensure that all DD audit related information is documented into the Audit Tracking system in a timely manner
  • Assess the appropriateness and timeliness of proposed CAPAs, and track designated CAPA follow-up to close for DD sites globally
  • Read and extract developing regulations and trends from available sources to provide recent perspectives during audits
  • Support 3rd party qualification activities
  • Train and support regional- and local DD manager and monitor effectiveness of training and compliance to requirements
  • Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
  • Establish and maintain the corporate process and procedures for QA Due Dilligence
  • Support implementation and adherence to the corporate QA Due Dilligence process at local and regional sites for local product acquisition and in-licensing deals

Your profile:

  • Bachelor Degree (Master Degree preferred) in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
  • At least 10 years in the Pharmaceutical Industry; and at least 5 years of GXP Auditing experience, leading audits related to GMP, GDP or ISO for Pharma,
  • Medical Devices and Nutritional product types
  • Strong knowledge and understanding of the EU, FDA, PICs, WHO and other relevant GMP, GDP and ICH guidelines and regulations, including ISO 9001 and ISO 13485
  • General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology
  • Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional and local objectives
  • Capable of analyzing data in in order to support the development of strategies to effectively manage the action plans that will resolve the issues
  • Excellent verbal and written communication skills in Business English
  • Excellent project management skills
  • Excellent knowledge of data integrity regulations and requirements

We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:

  • A job in a crisis-proof pharmaceutical company
  • An international working environment in a constantly growing company
  • A quality and customer-oriented environment
  • A motivated, agile and service-oriented team
  • Interesting and highly diversified tasks that provide a broad basis for your future career in the pharmaceutical industry
  • Attractive salary
  • Flexible working hours (possibility of home office)

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Please apply via our HR system here.

Note that only direct applications via our HR system (follow the link above) will be considered.

Further Information

Our team is happy to respond to any questions about the role or Acino you may have:

hr.international@acino.swiss

We are looking forward to hearing from you.

Only direct applications are considered.

 

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