Senior GMP/GDP QA Manager USA

Location: 

Radnor- Philadelphia Area, PA, US

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub and with US Corporate offices in both Radnor, PA and Cherry Hill, NJ, Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for a Senior GMP/GDP QA Manager USA to join our team.

 

Job Responsibilities

 

•    Provide GMP/GDP expertise from a US prospective ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards, in alignment with global quality and close collaboration with headquarter.
•    Perform GMP/GDP onsite audits at relevant Contract Manufacturing Organizations (CMOs), Warehouses and Distributors
•    Support the preparation of Quality Agreements in collaboration with CMOs and peers in the Idorsia organization
•    Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation
•    For the relevant scope of activities in the US, ensure follow-up of deviations, complaints and Corrective and Preventive Actions (CAPA)
•    Notify management of potential quality and regulatory issues
•    Establish a quality risk management approach in the US affiliate based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
•    Support the review and optimization of the company’s pharmaceutical quality system by establishing relevant Key Performance Indicators.
•    Support actively the organization in matters of regulatory requirements, technology and training.
•    Ensure that GDP compliance of the external and internal facilities, utilities, systems and equipment is maintained
•    Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP /GDP standards and for process improvement
•    Coordinate, plan and manage local Regulatory Agency Inspections (FDA).

 

Candidate’s Requirements

 
•    Advanced college degree in Pharmacy (preferred), Chemistry or alternative technical/science college degree
•    Minimum of 5 years’ experience in different positions within pharmaceutical development or manufacturing, quality control, analytical development or similar operational positions in the pharmaceutical industry
•    In addition, minimum of 3 years’ experience in quality assurance of drug product distribution covering also combination products
•    Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards
•    Knowledge of drug product manufacturing, control, packaging and distribution procedures
•    Strong interpersonal and influencing skills, ability to work in an international and matrix environment.
•    Excellent verbal and written communication skills.
•    Ability to manage multiple tasks with competing priorities
•    Entrepreneurial mind set combined with cost consciousness

 

What Idorsia offers

 

•    Exciting opportunities for development and professional growth within our dynamic organization
•    A collaborative and solution-oriented environment where you can make a difference
•    An innovative and open culture in a truly multicultural environment
•    A competitive salary and generous social benefits

 

Work Location: Radnor, PA, US

Country: United States of America

Business Area: Quality Assurance

Schedule: Fulltime

Job Type: Permanent

Job Code : 2206

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.


Nearest Major Market: Philadelphia