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Lead, Quality Compliance

2 weeks ago

Tuas, Singapore Novartis Full time

**Summary**:

- Manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) -Performs preparation and management of external and corporate audits and Health Authority inspections.

**About the Role**:
**Major accountabilities**:

- Planning and supporting PQR/APQR activities.
- Support site qualification and validation activities (planning, advising, review).
- Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit).
- Preparation/support and coordination of CAPA/follow-up -Audit and inspection preparation and support -Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc) -Ensure process quality assurance acc.

**Key performance indicators**:

- Successful support of projects with agreed quality and delivery dates, passing of internal and external inspections.
- Meet quality and timelines for all projects -Act in accordance with Novartis standards.
- The number and severity of cGMP issues identified during internal and external audits -Year-end figures within budget; Successful coordination of departmental operational activities

**Minimum Requirements**:
**Work Experience**:

- Functional Breadth.
- Collaborating across boundaries.
- Project Management.
- People Leadership.

**Skills**:

- Audit Management.
- Auditing.
- Communication Skills.
- Compliance Audits.
- Compliance Risk.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gmp Procedures.
- Inspection Readiness.
- Organizational Skills.
- People Management And Leadership.
- Qa (Quality Assurance).
- Regulatory Compliance.
- Risk Management.
- Self Awareness.
- Technological Expertise.

**Languages**:

- English.

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.