JOB DESCRIPTION:

Primary Job Function:

Oversight of assigned TPM sites for Product, Site & Quality compliance.
Lead and guide the team for TPM Operations and functionality on GMP aspects and Abbott policies and procedures, though site visits and ensure an audit readiness of sites.
Ensure Quality Agreements in place with the TPMs & assess site performance through the Quality metrics on periodic basis.
Ensure Pharmacopoeial compliance of Abbott products manufactured at sites.
Ensure implementation of Abbott quality audit CAPA & closure at sites.
Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check.
Coordinate with responsible CFT for NSQ's, Govt Agency responses.
Review & assess change controls, deviations, OOS/Failures, stability data related to Abbott products.
Monitor and support projects as assigned by the Manager.
Tech Transfer at TPMs including Analytical method transfer, FLQR (First Lot Quality Review )
Ensure and review GSR notifications and timely compliance at TPMs impacting Abbott products
Ensure compliances related to regulatory changes impacting Abbott products and processes.
Recruit, mentor, train and develop TPM QA India team members.
Prepare Risk assessment for critical observations and concerns identified while TPM audits of with appropriate mitigation actions.
To perform assessment of new site for cGMP compliance as and when required.

Stakeholder Management

Set and manage of expectations with stakeholders (Commercial, Planning, TPMs, MS&T, Regulatory, Labelling w.r.t Quality and Regulatory compliance.
Support AVD projects , Tech transfer projects, New product introductions as per Abbott process and policies.

Expectations & Skills :

Leverage knowledge, people networks inside and outside the company, out of the box thinking to resolve problems impacting Quality and regulatory challenges etc. impacting Abbott business.
Flexible, proactive and motivated by the opportunity to optimize structures and processes
Work collaboratively with colleagues to achieve organizational goals
Ability to adapt in a high pressured an ever-changing business environment
Ability to constructively cope with conflicts
Strong and proven analytical, organizational and decision-making skills
Strategic thinking, result and compliance oriented
Good interpersonal and communication skills
Resolution driven with adequate technical expertise
Ability to work efficiently in complex and deadline-driven operations, not losing focus on accuracy and quality
Proven track record to set priorities and adapt them accordingly at short notice
Effectively work on multiple, unrelated projects simultaneously
Provide expert guidance to team and CFTs on quality aspects and requirements supporting business
Ability to influence others. Intercultural competence.
Ability to understand the impact of business development decisions and contractual language on the Operations organization.
Ability to handle large volumes of confidential information and data and be able to determine how and when to inform upper management on quality related matters. Have a good control on Product database related to Quality.

Team Management

Develop a high-performance team by continuous monitoring and provision of guidance to develop the team
Identify improvement areas and conduct/drive initiatives for training sessions to upskill people to ensure functional knowledge of process.

Position Accountability/Scope:

Key contact for Quality aspects for South Zone sites & products.
Support and navigate to CFTs for Quality related matters for impacted products
Quality Technical Agreements.
Compliance to Abbott procedures and policies.
Tech Transfer and FLQR
Metrics review and management review.
Change Control Management
Implement Quality policies and EQDs.
Ensure an efficient exchange of information and a close working relationship with the CFTs for regulatory and Pharmacopoeial changes impacting Abbott products
Provide guidance to TPMs for the compliances and investigation support for quality failures like Market complaints investigations, OOS, OOT.
Establish and maintain an expanded network of contacts to share best practices, expertise related to Quality and Regulatory changes.
Promote quality and compliance, simplification and standardization in Divisional TPM QA

Leadership / Team leading:

Minimum Education:

Minimum Experience/Training Required:

20 years of experience in NPI, QC / QA, QMS, R&D QA, TPM Management, Tech Transfer, Dossier review, Due Diligence of products and sites.
Required to have managed TPM's in a significant capacity.
Knowledge of regulations of markets such as Latam, APAC, EU is required

Languages:

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

EPD Established Pharma

India Mumbai : BKC Building

Standard

Not specified

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)