Berufsbezeichnung: Senior Manager, Global GMP Compliance

Arbeitsbeschreibung:
To strengthen our Lonza Global GMP Compliance Department, we are looking for an exceptional Senior Manager, Global GMP Compliance, based at our Basel HQ and reporting to the Head Global GMP Compliance

Role Purpose:

Develop, plan and execute a program of corporate site GMP compliance audits/assessments for Lonza’s Pharma & Biotech GMP sites covering sterile and non-sterile drug products, biological and chemical APIs, medical devices and excipients. Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements. Advise, guide and support sites in the overall regulatory inspection management. Provide expertise to sites and the global organization on GMP compliance and best practices as well as new and developing GMP regulatory requirements and trends. The role will involve a large amount of international travel (up to 50%).

Key Accountabilities and Duties

Global GMP Compliance Audit/Assessment Management
•    Develop audit plans/agendas for corporate GMP compliance assessments/audits based on risk taking into account current regulatory focus and business needs
•    Execute corporate GMP compliance audits/assessments as part of the Global GMP Compliance Group (as lead or co-assessor/auditor)
•    Produce timely, detailed and technically correct reports following assessments/audits
•    Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads
•    Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements.
•    Approve proposed CAPA/ remediation plans, regularly review progress & effectiveness, and continue to give ongoing support in all compliance matters
•    Complete and maintain the corporate internal audit/assessment documentation and follow-up/tracking system where applicable

Regulatory Inspection Management
•    Conduct pre-approval/pre-submission project reviews (e.g. products, facilities), “mock” inspections as part of the Global GMP Compliance Assessment program.
•    Provide guidance for timely remediation
•    Advise, guide and support sites in the overall regulatory inspection management
•    In cooperation with other LGQ functions, review and provide input to commitments made to regulators following regulatory inspections
•    Provide advice and on-site support to sites during regulatory inspections as requested by Head of Global GMP Compliance

Customer Audits
•    Provide advice, guidance and support to sites for customer audits, as requested

GMP Compliance Risk Management
•    Perform regular analysis of regulatory observations made at Lonza’s sites, prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence and provide advice to the sites
•    Provide expertise to sites and the organization on new and developing GMP regulatory requirements and trends, to help ensure the company remains up-to-date with current GMP
•    Participate in the continuous improvement and maintenance of a global platform for reporting, reviewing and trending GMP Compliance risks on global basis

Other activities
•    Participate and lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives
•    Ensure expertise in GMP is kept current through involvement in Industry forums and conferences
•    Fulfil role as a technical reviewer and approver of GROUP GMP procedures and policies
•    Develop GROUP Quality standards and processes based on expertise and assigned areas

Who you are

You are someone who is a self-starter with excellent communication, organization, documentation skills. You are someone with a strong interpersonal and collaboration skills across functions and different hierarchical levels. You are someone who is able to work across cultures, plants, functions and influencing resources not under direct control. You’re looking for a company where you have the opportunity to pursue your aspirations, where a job abstractJV_title is not considered the final definition of who you are, but the starting point. Furthermore you have the following skills, experience and qualifications:

•    MSc in biochemistry/biologics, chemistry, pharmacy or equivalent
•    Fluent in English, German, French
•    Extensive experience/expertise/knowledge:
o     in Quality Assurance / Quality Systems experience in a cGMP environment (obligatory)   > 10 years
o    as a GMP auditor  (obligatory)   ≥ 5 years
o    in international regulatory inspection management incl. USFDA  (obligatory)   ≥ 5 years
o    in biological or chemical APIs, sterile/non-sterile Drug Product, excipient  Quality assurance (obligatory)   ≥ 5 years
o    International experience (obligatory)   ≥ 3 years
o    in CSV and Data Integrity (advantageous)
o    as Health Authority inspector (advantageous)
o    of both chemical and biological API and Drug Product operations (advantageous)
o    working in CMO environment (advantageous)
o    in international GMP regulations and guidelines especially in US / EU (obligatory) for drug products including CT/VT, APIs, medical devices, excipients and combination products

What we offer

We offer an excellent work environment where you can develop your skills and knowledge, the opportunity to work in a team of highly collaborative experts in a fun and dynamic atmosphere, and competitive salary and benefits. At Lonza we invest in great people. We encourage our employees to challenge themselves, and we offer an environment that fosters creativity and success. With headquarters in Basel, Switzerland, we operate production, R&D and business sites around the world, including Europe, North America and Asia.

Have we piqued your interest?

If yes, then we would be delighted to receive your application (detailed and updated CV + Cover Letter).
Important:
When applying for this role, please use the ‘cover letter’ or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Wie Sie sich bewerben:
ryad.amichi (at) lonza.com

Angestelltenname: Lonza AG