You are a key resource for Data Integrity, overseeing training, compliance, and investigations while collaborating with various teams to improve quality and consistency across operations.
Anforderungen
- •3 or more years in QA
- •Experience in GMP regulated environment
- •Good communication skills
- •Experienced in problem solving
- •Continued learning mindset
- •Responsible and reliable delivery
- •Good cooperation in teamwork
- •Fluent English (written and spoken)
Deine Aufgaben
- •Act as subject matter expert for Data Integrity inquiries.
- •Establish and maintain a network of DI SMEs across GMP functions.
- •Collaborate with DI SMEs to promote behavioral change and strengthen DI culture.
- •Provide quality and compliance oversight for material suppliers.
- •Identify DI training needs and develop relevant materials.
- •Facilitate DI training delivery.
- •Provide support for DI-related investigations and audits.
- •Serve as SME for DI during audits and inspections.
- •Lead execution of the site DI Plan and report progress.
- •Manage contractor qualification and oversight activities.
- •Align with contractor managers to ensure consistency.
- •Support implementation of global DI processes.
Deine Vorteile
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
Original Beschreibung
# QA Compliance Expert
**Schaftenau** | **Full time**
**Band**
Level 4
**Job Description Summary**
The QA Compliance Expert ensures compliance and drives continuous improvement of quality systems related to Data Integrity (DI) and contractor management. This role supports the implementation of efficient, sustainable processes that meet regulatory expectations across the global Novartis product portfolio. This role is open for part-time and job sharing.
**Job Description**
**Key Accountabilities**
* Act as site subject matter expert (SME) for all Data Integrity (DI) inquiries and DI training.
* Establish and maintain a network of DI SMEs/Champions across GMP functions (e.g. Manufacturing, QC, Automation).
* Collaborate with DI SMEs/Champions to promote behavioral change and strengthen DI culture; provide quality and compliance oversight for material suppliers supporting other NPMG sites
* Identify DI training needs, develop relevant materials, and facilitate training delivery.
* Provide site support for DI-related investigations, escalations, reviews, and audits (internal and external); serve as SME for DI and contractor/supplier management during audits/inspections
* Lead and monitor execution of the site DI Plan, including communication and engagement activities; report progress to site leadership.
* Manage contractor qualification and oversight (quality agreements, audits, risk assessments, surveillance planning).
* Align with contractor managers across the campus to ensure consistency and best practices; support implementation of global processes related to DI and contractor/supplier management
**Essential Requirements:**
* At least 3 years or more experience in QA
* Work experience in a GMP regulated environment in the pharmaceutical industry
* Good communication skills, Experienced problem solving
* Continued learning (dynamic knowledge development)
* Takes over responsibility and delivers reliably
* Teamwork: Good Cooperation with different Departments and Functions
* Fluent knowledge of English language (written and spoken)
**Skills Desired**
Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Model