Quality Management System Sr Specialist

**Summary**:

- Ensure the implementation, control and maintenance of the Quality System at Novartis, in accordance with current regulatory requirements, both national and international, and the guidelines of the Corporate Quality Manual that ensure and evidence the quality of the products marketed in Americas region and compliance with established guidelines.
- Support the Quality Organization in assuring compliance of the QC Laboratory operations in Mexico (QLS).

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

- Always ensure, and as a priority, compliance with the concepts of data integrity in Quality operations.
- Execute or review any data analysis required as delegated by _Partners_, such as trend reports or product reviews.
- Track and execute reports on metrics and compliance through the key quality indicators (KQI) on the applicable global platforms for Partners visibility.
- Responsible for opening, owning, managing, approving or following up (as applicable) the deviations and/or related child records, in accordance with company and regulatory requirements.
- Follow-up the status of actions arising from Quality Systems.
- Support as the Quality Expert in inspections (internal or external) related to GMP/GLP topics.
- Support on the oversight of laboratory operations as delegated or back-up of the QA manager for QC role, to ensure compliance with internal and regulatory requirements. Being responsible for:

- The review and approval of laboratory deviations and investigations.
- Support the laboratory to manage Data Integrity topics (e.g. DI Walkthrough reviews, DI plan commitment and promote DI culture).
- Administer the 1QEM system as a superuser in terms of access requests for profiles, profile registrations and deregistration or changes, and provide support during escalations to the global teams in 1QEM, in case of system failures.
- Reviews and approves validation protocols/reports, stability documents, specifications, work orders, change controls, SOPs and any other site product related to quality control documents aligned with his/her role, ensuring adequate level of documentation is present and compliant with existing procedures and regulations.

**Key performance indicators**:

- Ensure compliance with quality systems and corporate requirements.
- Support adherence for Quality KPIs.
- Zero critical findings in local, internal, and corporate Quality and Safety audits.
- Ensure adherence to the ALCOA + principles in routine activities
- Positive feedback from the parties involved in the processes under his/her responsibility.

**Minimum Requirements**:
Professional related to Chemical-Biological areas: Chemistry, Pharmacy, Biochemist, or related career.

At least 5 years’ experience in a Quality organization or equivalent.

**Work Experience**:

- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech.
- Collaborating across boundaries.

**Skills**:

- Continuous Learning.
- Dealing With Ambiguity.
- GMP Procedures.
- QA (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.

**Languages**:

- English.

Division

Operations

Business Unit

Universal Hierarchy Node

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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