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:

• Lead cross-functional, key contacts for Quality Aspects to support business.

Minimum Education:

• B Pharm /M. Pharm / Master in Science
• Any additional education is an added asset.

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:

• Proficiency in English
• Other languages are advantageous

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

DIVISION:

EPD Established Pharma:

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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