Director of Quality and Compliance — Interim, Biologics

The mandate

The organisation is midway through a quality-system strengthening programme. Hundreds of corrective actions are nominally closed, yet the chief quality officer cannot demonstrate that the underlying controls operate consistently.

The interim must join within three weeks for sixteen months, carrying the programme through independent verification and the next major inspection. A permanent director search begins after the first successful mock inspection, with six weeks allocated for transfer.

The exit condition is a regulator-accepted closure package, ninety-five per cent on-time quality-system performance for two quarters, no overdue critical CAPA, and a successor able to defend the evidence trail during an unannounced simulation.

The director may reopen weak CAPA, reject validation packages, assign independent reviewers and approve specialist support below ₹75 lakh. Facility capital above ₹3 crore and disciplinary action against site quality heads need executive approval; batch release and clinical-safety decisions remain outside this programme seat.

Pipeline prioritisation, commercial supply allocation and R&D method development are excluded. The work concerns durable quality-system control, not ownership of every scientific or production decision touching the biologics portfolio.

Why this seat is open

External reviewers found that reported completion outran objective evidence. The programme leader left before the board could agree a recovery plan. An interim with inspection credibility is required to reopen uncomfortable actions, restore the evidence standard and then relinquish the programme to permanent quality leadership.

What you will own

• Triage every consent-decree commitment by patient risk, evidence weakness and inspection dependency, then rebaseline closure dates.
• Reopen corrective actions whose effectiveness checks rely on attendance, policy issue or unsupported self-certification.
• Establish independent approval for validation protocols, deviations, sampling rationale and final reports.
• Decide where temporary quality-system controls are necessary until technology or facility remedies become effective.
• Run three escalating mock inspections and convert observations into dated, verified recovery actions.
• Issue a monthly evidence-integrity opinion to the compliance committee, including actions shown as complete but not proven effective.
• Coach the permanent appointee through an unannounced simulation using the final regulator-response archive.

Candidate qualifications

• At least eighteen years in biologics or sterile-product quality systems, including senior inspection and remediation leadership.
• Direct experience under a consent decree, warning letter or comparable formal regulator-enforcement programme.
• Advanced command of CAPA effectiveness, computer-system validation, process validation, data integrity and audit-trail review.
• Evidence of challenging premature closure decisions and defending the revised position before executives and inspectors.
• Ability to structure large remediation portfolios without allowing programme metrics to substitute for patient-risk judgment.
• Prior handover of a quality recovery programme to an internal or newly hired permanent director.