DGM / Head - Quality Control (Solid Oral Dosage)

Role & responsibilities

QC Operations & Laboratory Leadership

• Provide overall leadership for Quality Control operations supporting a large-volume Solid Oral Dosage manufacturing facility.
• Ensure timely testing and release of raw materials, packaging materials, in-process samples, finished products and stability samples in accordance with approved specifications and regulatory requirements.
• Drive laboratory capacity planning, workload management, resource optimization and adherence to testing and release timelines.
• Ensure effective management and utilization of analytical instrumentation including HPLC/UPLC, GC, dissolution systems, UV, FTIR and other sophisticated laboratory equipment.
• Establish robust laboratory performance metrics covering turnaround time, right-first-time, investigation trends, repeat testing, analyst productivity and equipment utilization.

Regulatory Compliance & Inspection Readiness

• Ensure QC laboratories operate consistently in compliance with cGMP, GLP and applicable global regulatory requirements, including expectations of USFDA and other major regulated-market agencies.
• Lead QC preparation and participation during regulatory inspections, customer audits and internal quality audits.
• Ensure timely and scientifically sound responses to regulatory observations and audit findings.
• Maintain the QC organization in a state of continuous inspection readiness rather than event-based audit preparation.
• Remain current with evolving regulatory expectations and translate them into laboratory practices and controls.

OOS/OOT, Investigations & CAPA

• Provide technical oversight for OOS, OOT, OOC, atypical results, laboratory incidents and deviations.
• Ensure investigations demonstrate strong scientific rationale, appropriate root-cause analysis and defensible conclusions.
• Review investigation trends and implement systemic CAPAs to prevent recurrence.
• Challenge weak investigations and strengthen the overall investigation capability of analysts and QC managers.
• Partner with QA, Manufacturing, Technical Operations and R&D for complex product and analytical investigations.

Data Integrity & Laboratory Systems

• Own and strengthen the site's QC data-integrity culture and controls.
• Ensure compliance of laboratory systems with applicable requirements including 21 CFR Part 11 and ALCOA+ principles.
• Drive appropriate governance of audit trails, electronic records, user access, data review, backup and archival processes.
• Ensure robust controls around chromatography data systems, LIMS and other digital laboratory platforms.
• Proactively identify potential data-integrity vulnerabilities and implement sustainable preventive controls.

Analytical & Stability Management

• Provide oversight for analytical method transfer, verification, validation and method lifecycle activities in coordination with R&D/Analytical Development.
• Ensure effective execution and governance of stability programs for commercial products.
• Review stability trends and ensure timely investigation of adverse or atypical trends.
• Provide technical leadership for analytical troubleshooting and method-related challenges.
• Ensure pharmacopeial and regulatory requirements are appropriately incorporated into specifications and testing practices.

Quality Systems

• Ensure effective execution of QC-related quality systems including:
  
• Deviations
• CAPA
• Change controls
• OOS/OOT/OOC investigations
• Laboratory incidents
• Method validation/verification
• Instrument qualification and calibration
• Reference and working standards
• Reagents and laboratory solutions
• Stability management
• Laboratory documentation and records
• Participate in site-level Quality Management Reviews and provide meaningful trends, risks and improvement actions.

Operational Excellence

• Drive continuous improvement in laboratory operations through automation, digitization, Lean laboratory practices and process simplification.
• Improve testing turnaround time without compromising scientific rigor or compliance.
• Establish appropriate KPIs and dashboards to monitor laboratory performance and identify emerging risks.
• Reduce avoidable repeat analysis, laboratory errors and investigation recurrence.
• Partner with Manufacturing and Supply Chain to support reliable product release and manufacturing schedules.

People Leadership

• Lead, coach and develop a large team of QC managers, scientists, officers and analysts.
• Build strong second-line leadership and succession pipelines within Quality Control.
• Develop scientific, investigation and regulatory capabilities across the QC organization.
• Establish clear accountability and a strong culture of quality, compliance, scientific integrity and ownership.
• Drive performance management, capability development and engagement of the QC team.

Preferred candidate profile

M.Sc. / M.Pharm / B.Pharm or equivalent qualification in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline.

• Approximately 20 to 25 years of progressive experience in Pharmaceutical Quality Control, preferably within large formulation manufacturing organizations.

• Significant leadership experience in Solid Oral Dosage Quality Control is essential.

• Currently operating at AGM/DGM/GM/Head-QC level, or managing a substantial QC function within a large regulated manufacturing site.

• Demonstrated experience leading sizeable QC laboratories and multidisciplinary teams.

• Strong exposure to products manufactured for regulated/global markets.

• Hands-on experience of major regulatory inspections, preferably including USFDA.

• Strong understanding of OOS/OOT investigations, data integrity, analytical systems, stability, method validation/transfer and laboratory computerized systems.

Leadership Competencies

The successful candidate should demonstrate:

• Strong scientific and analytical judgement
• Regulatory and compliance orientation
• High standards of data integrity
• Ability to lead large and complex laboratory operations
• Strong investigation and problem-solving capability
• Decision-making under pressure
• Operational excellence mindset
• Ability to challenge constructively and influence cross-functional stakeholders
• Strong people-development capability
• High ownership and execution orientation