Manager II - Health Authority Communications

Position: Manager II - Health Authority Communications

Reports to: Head of Health Authority Communication and Correspondence

Department: Global Quality

Functional Area: Global Quality

Location: Mumbai

POSITION SUMMARY

The Manager II - Health Authority Communications will be integral in supporting global health authority communications and ensuring regulatory compliance across the organization. This role assists the Head of Health Authority Communication and Correspondence by supporting the coordination of regulatory responses, managing quality deliverables, and preparing materials for regulatory meetings.

The incumbent will assure individual compliance with all concerned regulatory requirements, GxP and applicable department programs, including training, documentation, Standard Operating Procedures, and Global Quality Policies, Standards and Procedures.

This role is ideal for a Quality professional with experience in various manufacturing environments (e. g. , aseptic, solid oral dose) and Quality Management Systems, looking to support health authority communication, remediation, and identification/resolution of potential compliance risks.

Key responsibilities

1. Health Authority Correspondence Management - Assist in the review and preparation of scientifically accurate, compliant responses and commitments to health authority queries and inspection observations. Collaborate with site teams to gather necessary data and draft cohesive, concise responses. Track and manage all regulatory communication activities, ensuring accurate data entry and documentation within regulatory databases in a timely manner.

1. Quality Management System Analysis - Assess findings from inspections, audits, and Quality Management System to identify areas for global risk mitigation. Provide support to internal teams to develop appropriate corrective actions.

1. Inspection Readiness - Provides support for all regulatory audits, internal/external inspections, and other audits. Provides support for mock inspections, including review of documents for compliance to current regulations.

1. Compliance Tracking and Reporting - Monitor updates and perform gap assessment on regulatory requirements, especially related to aseptic environments and quality management.

1. Performs additional assignments as needed.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

• Degree in a Science/Pharmacy related field required.
• 7+ years of experience in quality within the pharmaceutical industry, including experience in an aseptic environment. Microbiology experience is desirable.
• Knowledge of GxP, cGMP, Quality Systems, and other regulatory requirements.
• Proficient in Quality Management Systems (QMS) with experience analyzing QMS data.
• Significant experience in global health authority inspections and audits in the pharmaceutical industry, and direct involvement as a team member in writing responses. Experience responding to FDA, MHRA, EMA, or WHO is preferred.

REQUIRED SUCCESS ATTRIBUTES

• Deep understanding of Quality Management Systems, e. g. , CAPAs and deviations.
• Proficiency with regulatory tracking systems and Microsoft Office Suite.
• Excellent attention to detail, technical writing, collaboration with cross-functional teams, and project management skills.
• Communicate effectively, orally and in writing, with internal stakeholders.
• Consistently adheres to policies and maintains high ethical standards in all actions.
• Ability to manage multiple priorities in a fast-paced environment and meet deadlines.
• Takes initiative and proactively identifies and acts on opportunities for improvement and problem-solving.

Secondary Success Attributes

• Commitment to continuous learning and staying updated with regulatory and industry best practices.
• Quickly adapts to new knowledge and eagerly embraces unfamiliar challenges.
• Participates in global harmonization activities.

Roles

Additional responsibilities can be assigned as required.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments in both normal office and manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled manufacturing areas, and wear personal protective equipment as required.

DELEGATION OF RESPONSIBILITY

In the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation - Strategic corporate responsibilities to higher level

Downward Delegation - N/A

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.