Senior Manager- Quality Assurance

Primary Job Function:

• Lead and guide the team for LLM Operations and functionality on GMP aspects and Abbott policies and procedures.
• Monitor compliance of Loan license manufacturing sites and TPMs.
• Perform LLM site visits on scheduled basis and ensure compliance of LLM sites to cGMP, Abbott policies and Procedures.
• Ensure Pharmacopoeial compliance of Abbott products manufactured at LLMs.
• Review ongoing stability data and control samples of Abbott products.
• Ensure implementation of Abbott quality audit CAPA & closure at LLMs.
• 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 at LLM sites related to Abbott products.
• Ensure QTA compliance at LLMs and ensure QTAs are in place for all LL/TPMs.
• Monitor and support projects as assigned by the Manager.
• Ensure review and approve documents for tech transfer projects @ TPMs and FLQR review and approval for all projects for existing products and changes.
• Review of change controls and approval for products at TPMs in Abbott system.
• 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 an effective communication process within cross functional team for execution of Quality projects supporting India Business.
• Ensure compliances related to regulatory changes impacting Abbott products and processes.
• Recruit, mentor, train and develop TPM QA India team members.
• Manage the CFT stakeholders including S& OP meetings, lead from the quality front.
• Ensure Deloitte Compliance across all LL sites including implementation of Abbott’s processes and compliance across all LL sites in coordination with LL site management

Data Management           

• Ensure all TPM and product related database is maintained and achieved for the TPM QA function.
• Customize Quality related procedures and Work instructions for the region as required for local requirement and its periodic review/ updates/ additions of SOPs to continuously improve processes and ensure compliance

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 for loan license sites and materials for requirement 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
• Works 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
• GMP and Regulatory requirement, TPM Management, Due diligence.
• 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.

Supervisory/Management Responsibilities:

Direct Reports:   - 02

Indirect Reports:  - Contingent Workers @ LLMs ( Around 50 for SAP users management)

Position Accountability/Scope:

• Key contact for Quality aspects for Loan License 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.
• Change Control Management
• Understand the overall Quality policies and EQDs and its implementation in India as per Global procedures.
• Ensure an efficient exchange of information and a close working relationship with the CFTs for regulatory and Pharmacopoeial changes impact ting Abbott products
• Provides guidance to LLM/TPMs for the compliances and investigation support for quality failures like Market compliant 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 global TPM QA

Leadership / Team leading:

• Lead cross-functional, key contact 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:

• 12 to 15 years of experience in Quality Control / Quality Assurance,  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

Languages:

• Proficiency in English
• Other languages are advantageous

The base pay for this position is

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