Head PID Governance and Process

JOB DESCRIPTION:

Primary Job Function

The Head Product Ideation and Design (PID) Governance and Process supports the efficient and compliant execution of PID (Product Development, Clinical Supplies, Pre-Clinical and Packaging) activities to internal and external standards by driving new innovative solutions to address PID Operational Excellence needs worldwide (global and regional and affiliate).

Core Job Responsibilities

Governance

• Responsible for creation and implementation of I&D PID self-assessment plan and related activities including evaluation of PID processes and performing risk assessment, proposing topics for self-assessment, aligning the plan with functional leaders, conducting, and reporting self-assessments and tracking and driving continuous improvement activities.

• Responsible for governance and process related activities within all PID functions (Pre-clinical, Clinical supplies, Packaging and Product Development).

• Responsible for collation and monitoring of KPI/ Quality parameters and other relevant regular metrices.

• Support PID functions for internal and external audits, internal management reviews

• Collaborate closely with Innovation & Development Quality function to ensure implementation of Abbott procedures.

• Drive continuous improvement and is a role model for best practice across the organization.

• Takes ownership of continuous learning to stay aware of evolving Abbott policies, regulations and industry practices affecting our procedural standards and quality system documents.

Process

• Ownership, coordination and maintenance of the Product Development functional Quality System documents and associated processes to ensure the smooth running of the quality system.

• Ensure Established Pharmaceutical Division (EPD) functional quality system documents are aligned to Abbott corporate and external standards (ICH GxP & relevant industry and regulatory requirements). Collaborates with functions to ensure harmony and synergy across common processes.

• Work closely with subject matter experts to create/ update functional Quality system documents - this includes developing deep understanding of each process to create high quality written procedures. Acts as author for procedures and responsible for content, has sufficient professional knowledge to make recommendations and facilitate discussion on procedural topics within and across functions.

• Ownership of department training content and training matrix and ensure personnel have appropriate training plans assigned (including Affiliates) and training plans are compliant with EPD procedures.

• Implement and track training compliance metrics and KPIs Identify and remediate areas of non-compliance in close collaborations with compliance functions like Quality, and Office of Ethics & Compliance (OEC).

• Promote and enhance training compliance and manages non-compliance.

• Identify operational training needs and coordinate training delivery, where appropriate.

• Develop and deliver engaging training content with support of internal and external subject matter experts. Responsible for managing relationships (including contractual deliverables) with external service providers where required.

Position Accountability / Scope:

• Responsible for the management of global PID governance and quality system documentation, associated training material, systems, administrative processes, and assignment.

• Internal stakeholders include PID team, Quality Assurance, Regulatory Affairs, Operations, Clinical Development, Office of Ethics and Compliance, I&D Centers.

• External stakeholders business partners (contractors, consultants, vendors)

Minimum Education

• Bachelor of Science in a field related to life sciences or equivalent by experience.

Experience:

• At least 12 years experience in pharmaceutical industry (experience in Product Development/ quality domains is required).

• A solid understanding of the key activities of Product Development, Pre-clinical, Clinical supplies, and Packaging and relevant external industry regulations.

• Experience with working in a Global fast paced environment.

• High standards and attention to detail, highly organized, capable of multi-tasking with minimal guidance to deliver right first-time content.

• Must be capable of working independently and applying professional learning and experience.

• Experience in authoring and reviewing procedural documents. Ability to communicate clearly in written and spoken English is essential.

• Proficient in MS office applications especially Excel and Word.

• Experience of records management/ quality control/ system management preferable.

• Ability to communicate effectively with stakeholders at all levels of the organization.

• Fluent in English.

The base pay for this position is

N/A

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

JOB FAMILY: Product Development

DIVISION: EPD Established Pharma

LOCATION: India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 20 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable