QA Compliance Manager (GMP/GDP)
QA Compliance Manager (GMP/GDP) - ( 170000BY )
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a QA Compliance Manager (GMP/GDP) in Allschwil.
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
The position of QA Compliance Manager is an exciting opportunity to manage a wide range of GMP/GDP auditing and compliance activities for drug substance and drug product by providing routine site support for Quality Compliance as well leadership and coaching to the site for the development and execution of GMP Quality Systems.
- Planning, scheduling, coordinating, conducting and reporting GMP/GDP self-inspections and external audits of Actelion suppliers of drug substance / excipients and drug product contractors i.e. manufacturers, distributors, packagers and labs.
- Establish external QA audit and internal self-inspection frequency based on risk assessment.
- Preparation and execution of the annual audit plan.
- Manage, review and approve change controls, deviations and CAPAs .
- Manage, review and approve of qualification & validation documents of GMP equipment and GMP processes.
- Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation for Actelion globally and for affiliates.
- Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP / GDP standards and for process improvement, including quality agreements with third parties and Actelion affiliates.
- Review and approve site GMP required procedures and ensures alignment and compliance with Corporate Compliance, Global site reviews, and JnJ Policies and Directives.
- Administer systems to monitor, track, and trend regulatory compliance i.e. deviations, CAPA, investigations, complaints, change controls etc.
- Support site regulatory inspections. Participate in the preparation of document packages and responses to regulatory agencies.
- Monitor changes in quality regulations and initiate required activities to keep the quality system aligned and compliant.
- Support, review and optimization of the company's pharmaceutical quality system by tracking and reporting key quality metrics for the site.
- Pro-actively participate in optimization of the quality system by proposing new procedures, tools or through modification of existing ones.
- Travel time in this role is estimated at 25%.
- A minimum master’s degree level of education in pharmacy, chemistry or alternative technical/scientific subject.
- 3-6 years’ experience managing GMP quality assurance auditing and compliance activities for drug substance / drug product.
- Additionally, several years of experience in different operational positions in pharmaceutical product development and manufacturing of oral and sterile dosage forms.
- Deep understanding of drug substance / drug product development, manufacturing process, quality control, packaging and distribution.
- Deep expertise of (c)GMP and GDP, able to interpret and implement quality standards, pro-actively initiate and lead quality compliance activities and manage complex projects / tasks with competing priorities.
- Able to work with a high degree of autonomy and self-management, proactively finding solutions to problems and knowing when to appropriately escalate issues.
- Self-confident and assertive with strong interpersonal and influencing skills, well able to manage all types of stakeholders and situations.
- Fluency in English (additional languages advantageous) and the ability to communicate clearly and professionally, both verbally and in writing is essential.
- Available to travel approx. 25% of the time.
If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.
Primary Location : CH-BL-Allschwil
Job : Quality
Schedule : Full-time
Job Type : Standard
Job Posting : Nov 15, 2017