About this opportunity
To lead, manage and monitor the Finished good section. To oversee the EHS and Quality Compliance of the lab.
Major Responsibilities:
Monitor FG release on time.
Monitor zero stockouts caused by QC delays (monthly).
Manage and monitor to qualify new instruments.
Prevent team failures through structured leadership.
Define roles, workloads, and cross-coverage; maintain a skills matrix.
Conduct routine tier meetings (Tier-1 daily, Tier-2 weekly, Tier-3 monthly).
Coach on data integrity, OOS/OOT, safety, and problem solving.
Zero compromise on compliance and data integrity.
Enforce ALCOA+ principles across paper and electronic records.
Review and approve SOPs, STMs, specifications, and logbooks; ensure version control.
Ensure validated computerized systems and controlled access.
Conduct internal audits; close CAPAs on time.
Audit/inspection observations: zero critical, minimal major; 100% CAPA closure on time.
100% adherence to document control and data integrity requirements.
Cascade departmental goals to individual SMART goals.
Monitor KPIs via dashboards; take corrective actions monthly.
Structured performance management and development.
Conduct goal setting at start of year; mid-year and year-end reviews.
Identify training needs and succession plans for critical roles.
Embed safety and environmental stewardship in Finished good section
Track and deliver EHS goals for QAD; participate in EHS audits and inspections.
Conduct chemical risk assessments, waste segregation, and proper disposal.
Report NMPI (Near Miss/Proactive Indicator) and close actions.
Zero lost-time incidents; 100% EHS training completion; near-miss reporting rate trending upward (positive culture).
Rapid resolution of analytical issues to protect supply and compliance.
Lead troubleshooting using scientific methods; document hypotheses, trials, and conclusions.
Engage OEMs for complex instrument issues; maintain service contracts and spares.
Facilitate method robustness improvements (system suitability, ruggedness).
Ensure integrity of all reported data and decisions.
Oversee vendor qualification testing and periodic supplier re-evaluation.
Govern OOS/LIR investigations per SOP; ensure root-cause depth and effective CAPAs.
Support Process Validation analytics (PPQ sampling plans, acceptance criteria).
Oversee CSV/GxP systems validation with QA/IT; manage change controls.
Represent QC in cross-functional forums, Quality Council, Change Review Board).
Approve urgent documents within delegated authority; manage crises and recalls with QA.
No disruption during delegation; timely decisions and communications recorded.
Education/Knowledge & Experience:
M.Sc. Chemistry / Pharm-D
8-10 years’ experience in the same capacity
Knowledge of requirement for QC/QA and all other activities taking place in QC/QA including knowledge of Annual product quality review.
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 304 comparable Manager Quality roles across 77 biopharma companies.
Salary context
62 of 304 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 304 comparable roles
+ 23 more countries
Seniority mix
304 of 304 peers have a known seniority level
Therapeutic area mix
0 of 304 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.