Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 13 days ago

Senior QA Manager, Customer Focus & Project Assurance

Piramal Pharma Solutions195 open roles

Where
Sellersville
Work mode
On site
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSenior QA Manager, Customer Focus & Project AssurancePiramal Pharma Solutions · Sellersville

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Piramal Pharma Solutions's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

8.5% of postings close within 7 days. Measured by our own scanner across the market. Piramal Pharma Solutions postings stay open a median of 21 days.

Share of postings closed within
  1. 1.8%1 day
  2. 4.0%3 days
  3. 8.5%7 days
  4. 15.4%14 days
  5. 34.1%30 days
This job: posted 13 days ago

Piramal Pharma Solutions median: 21 days open

The posting

Be the First to Apply

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior QA Manager, Customer Focus & Project Assurance

Job Description

The Senior QA Manager, Customer Quality & Project Assurance leads customer-facing Quality activities and ensures on-time execution of Quality deliverables across development, validation, commercial manufacturing, and product lifecycle programs within a CDMO environment. The role serves as the primary Quality partner to Project Management and coordinates with Manufacturing, Quality Control, Regulatory Affairs, Technical Services, Validation, Supply Chain, and other functions to meet customer commitments and maintain cGMP compliance. This role is designed as the primary Quality liaison for customer programs and would fit well within your proposed Quality organization as the leader responsible for all customer-facing Quality operations, project quality execution, customer audits, complaints, investigations, APQRs, batch disposition support, and customer satisfaction. It also provides a logical career progression path to Senior Manager, Customer Quality & Project Assurance as the CDMO business expands.

KEY ACCOUNTABILITIES

The incumbent oversees approximately 4–6 Quality professionals and is accountable for batch disposition, deviations, laboratory investigations, OOS/OOT events, complaints, APQRs/PQRs, customer audits, CAPAs, Quality Agreements, and related project commitments. This role leads Quality Operations, Clinical Operations, Commercial Operations, Data Auditing, and QA IT support, and serves as the Quality leadership designee as needed.

· Customer Quality Leadership: Serve as the primary Quality contact for assigned customers; build trusted relationships; lead routine Quality reviews and escalations; and ensure transparent, timely communication.

· Project Quality Execution: Partner with Project Management to define, prioritize, track, and deliver Quality activities aligned with project plans, customer expectations, technical milestones, and commercial schedules.

· Batch Release and Product Disposition: Coordinate timely QA review of batch records, test results, deviations, investigations, and supporting documentation required for disposition while maintaining independent Quality authority.

· Quality Events and Investigations: Oversee deviations, nonconformances, laboratory investigations, OOS/OOT events, and product-impact assessments. Ensure investigations are scientifically sound, risk-based, and completed within approved timelines.

· Customer Complaints: Lead complaint intake, investigation, response, trend review, and escalation. Ensure customer responses are accurate, clear, compliant, and issued within established commitments.

· CAPA Management: Ensure CAPAs address root cause, include accountable owners and milestones, are completed on time, and contain meaningful effectiveness checks.

· Customer Audits: Lead audit planning, readiness, execution, response development, commitment tracking, CAPA closure, and effectiveness verification. Coordinate SMEs and cross-functional support.

· Annual Product Quality Reviews: Oversee accurate and timely preparation, review, approval, and customer delivery of APQRs/PQRs, including evaluation of product, process, investigation, complaint, and CAPA trends.

· Quality Agreements and Commitments: Support development and maintenance of Quality Agreements and ensure customer notifications, responsibilities, deliverables, and commitments are clearly assigned and fulfilled.

· Risk, Metrics and Escalation: Maintain dashboards for release cycle time, event closure, CAPA, complaints, audits, APQRs, and customer commitments. Escalate significant quality, compliance, schedule, and resource risks with recovery plans.

· Continuous Improvement: Use metrics, lessons learned, risk assessments, and customer feedback to improve right-first-time performance, cycle times, investigation quality, and customer experience.

· People Leadership: Lead, coach, and develop approximately 4-6 Quality professionals. Set priorities and performance expectations, allocate work, build capability, and foster accountability, collaboration, engagement, and a strong Quality culture.

EDUCATION / EXPERIENCE

· Education: Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or a related scientific discipline is required. An advanced degree is preferred.

· Industry Experience: Minimum eight (8) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences, including work in a cGMP manufacturing environment.

· Leadership Experience: Minimum three (3) years of direct people-leadership experience, including responsibility for workload planning, coaching, development, and performance management.

· CDMO Experience: Experience supporting multiple customers and products in a CDMO/CMO environment is strongly preferred.

· Customer and Project Quality: Demonstrated experience managing customer-facing Quality activities and partnering with Project Management and cross-functional teams to meet project milestones.

· Quality Operations: Experience with batch disposition, deviations, investigations, OOS/OOT events, complaints, CAPAs, APQRs/PQRs, change controls, customer audits, and Quality Agreements.

· Regulatory Knowledge: Strong working knowledge of 21 CFR Parts 210 and 211, EU GMP, ICH guidance, data integrity expectations, and risk-based Quality decision-making.

· Systems: Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.

JOB COMPETENCIES

· Customer-focused leadership with sound, independent Quality judgment.

· Strong project management, prioritization, organization, and follow-through.

· Excellent written, verbal, presentation, negotiation, and stakeholder-management skills.

· Demonstrated investigation, root-cause analysis, problem-solving, and risk-assessment capability.

· Ability to influence cross-functional teams, manage competing priorities, and hold owners accountable for timely execution.

· Ability to balance patient and product protection, regulatory compliance, customer commitments, and business continuity.

· Ability to lead through change and foster a collaborative, accountable, and improvement-oriented team culture.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Piramal Pharma Solutions's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Piramal Pharma Solutions's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Piramal Pharma Solutions's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.