Chief Manufacturing Officer — Interim, Formulations

The mandate

A regulator warning identified recurring data-integrity and contamination-control failures, and the manufacturing chief resigned after the board rejected the initial response. Supply commitments across regulated markets are now threatened by remediation downtime and low right-first-time performance.

The incoming executive must start within three weeks and serve for twenty-four months, encompassing remediation, inspection and performance recovery. The role dissolves when a restructured operations model installs permanent site leadership; conversion is not contemplated.

Handover is complete after all critical observations are verified closed, two major inspections conclude without repeat findings, schedule adherence exceeds ninety-two per cent for six months, and each plant head passes a board-observed operating review without interim support.

The interim can stop lines, reallocate production among approved sites, approve remediation work below ₹4 crore and replace contracted technical resources. Capital above ₹10 crore, permanent plant-head appointments and market withdrawals require board authority; batch disposition remains independently owned by Quality.

Product-development priorities, sales allocation among customers and acquisition diligence are out of scope. The manufacturing office must neither override Quality nor use urgent supply as grounds to dilute validated controls.

Why this seat is open

The regulatory response exposed a deeper loss of operating credibility than the previous chief acknowledged. Site leaders need one executive who can balance remediation sequencing with constrained supply. The board has chosen a long but finite interim window because inspection evidence must mature before authority can return to the permanent structure.

What you will own

• Convert regulator observations into a plant-by-plant remediation critical path with evidence owners and independent verification gates.
• Decide line shutdown and restart sequencing using patient supply, contamination risk and qualified alternative capacity.
• Rebuild tiered performance reviews around deviations, right-first-time output, schedule adherence and maintenance reliability.
• Approve temporary technical expertise and remediation spend within delegated limits, documenting value and exit dates.
• Establish a manufacturing data-integrity control system spanning equipment, laboratories, batch records and privileged access.
• Present inspection readiness and residual supply risk monthly to the compliance committee without softening adverse evidence.
• Transfer control to permanent plant heads through observed reviews, signed site dossiers and two unassisted inspection simulations.

Candidate qualifications

• Twenty-eight or more years in pharmaceutical manufacturing with enterprise authority across multiple regulated-market plants.
• Personal leadership of remediation following a warning letter, import restriction or comparable high-severity regulatory action.
• Deep expertise in sterile or complex formulations, contamination control, data integrity, validation and batch-record discipline.
• Demonstrated recovery of schedule adherence and right-first-time performance while significant assets were unavailable.
• Mature understanding of the independence between Manufacturing and Quality, including batch disposition and escalation boundaries.
• Experience developing plant heads to operate under direct board and regulator scrutiny after a central turnaround team exits.
• Credible inspection-room presence with concise, evidence-based communication to international regulators.

Non-negotiables

• Can be Hyderabad-based within three weeks and travel extensively among four plants.
• Has no active role with a competitor supplying the same regulated markets.
• Accepts a twenty-four-month fixed assignment with no presumption of a permanent seat.
• Will uphold independent Quality release authority regardless of shipment pressure.

1. 49 words maximum. What is your earliest start, and can you commit to four-plant travel for twenty-four months?
2. 49 words maximum. Which repeat regulatory finding did you close, and what evidence convinced the inspector it would not recur?
3. 49 words maximum. Describe one line you kept stopped despite supply pressure and the restart gate you required.