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Director/Sr. Director, Quality Assurance Operations

Genezen · Lexington, MA

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Level
Director+
Team
Quality
Base pay
$170k–$240k
Degree
Required
Experience asked
10+ years
Industry
Pharma & life sciences
Posted
Yesterday

The role in 30 seconds

A director-level quality role at Genezen (pharma & life sciences) in Lexington, MA.

They ask for
10+ years · degree required
Tools it names
CAPA, FDA / GMP, Validation (IQ/OQ/PQ)
Base pay
$170k–$240k

Read from the posting. The full description is below.

From the plant jobs report · week of October 19, 2026

Quality Engineer roles in Massachusetts: typical posted base $107k–$149k. This one lists $170k–$240k.

Median of the low and high ends of 50 live postings that list pay, out of 70 quality engineer openings in Massachusetts, read from manufacturers' own careers sites.

Massachusetts plant jobs report →Pay by team and state →What moves pay →

How this role compares

Against 69 other live quality postings in Massachusetts.

Base pay
About 72% above similar roles

Typical $100k–$138k, from 39 postings that list pay.

Experience asked
More than usual (10+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • Root cause 69%
  • ✓ FDA / GMP 60%
  • ✓ Validation (IQ/OQ/PQ) 51%
  • ✓ CAPA 50%
  • ISO 13485 46%
  • FMEA 37%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 10+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

At a glance

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at Genezen

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • How did you land the job? What stood out in your interviews?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

This plant: Genezen in Lexington

8 other open roles at this site.

All 9 roles at Genezen →
Full description from GenezenAs posted on their careers site.Show

Job summary

The Director of Quality Assurance is responsible for oversight all elements of the Quality Management System (QMS), ensuring processes adhere to global cGMP regulations. This includes quality oversight of all GMP functions including but not limited to Facilities, Engineering, Validation, Manufacturing , Quality Control Laboratories, Supply Chain, Packaging and Labeling, Distribution, and external Suppliers.

The Director of Quality Assurance is responsible for building and motivating a high performance and innovative Quality Assurance organization which enables a culture of compliance, trust and accountability, efficient execution, collaboration for success, and integrity and respect in order to deliver transformative gene therapy medicines.

requirements

aligned with global regulations and internal Quality Management Systems.

  • ✓Manages investigations and implements timely and effective CAPA.
  • ✓Manages the review and disposition of raw materials, intermediates, drug substance , and drug product and ensures timely and accurate completions of reported quality events.
  • ✓Provides Quality Assurance support to the following operation areas: Manufacturing, MSAT, FEV, Q uality Control, Supply Chain.
  • ✓Responsible for developing, implementing and improving Quality System Metrics and for reporting performance trends and risks to senior management.
  • ✓Supports a risk - based internal and external audit program.
  • ✓Responsible for hosting and supporting the management of PAI and all subsequent routine global health authority inspections.
  • ✓Responsible for assessing the impact of any new or updated regulations on the company’s Quality Management Systems and operations.
  • ✓Responsible for developing and maintaining a high-performing Quality Assurance organization to effectively execute organizational responsibilities.
  • ✓Responsible for managing and maintaining strong Quality to Quality relationships with clients.

Requirements

  • ✓Adaptability required as work schedule may change based on business needs.
  • ✓Criminal background check required.
  • ✓Other duties as assigned

Knowledge, skills and experience

Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering

Experience working in a cGMP manufacturing environment

Essential

Well versed in cGMP/ICH/FDA/EU regulations and guidelines

Essential

Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)

Essential

Strong written and verbal communication skills to interact with cross function teams

Essential

Strong organizational skill

Essential

High level of attention to detail

Essential

Good problem-solving skills

Essential

Capable of working with minimal supervision

Essential

Ability to work well with diverse groups

Essential

Ability to multi-task in a fast-paced environment with challenging timelines

Essential

Show full description ↓

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Working at genezen

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

Essential job functions

  • •Manages development, implementation, maintenance, and improvement of all relevant Quality Management Systems and processes to ensure compliance in line with global regulations and in alignment with the company’s strategy.
  • •Provides guidance to operations on phase appropriate cGMP

Desired

10+ years of relevant GMP experience in the pharma/biotech industry in a Quality role

Essential

Physical demands

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • •Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
  • •Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
  • •Occasionally exposed to moving mechanical parts; caustic chemicals; hazardous waste.
  • •Occasionally exposed to loud noise levels
  • •Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement

  • •Frequently required to stand; sit.
  • •Occasionally required to walk; climb or balance; and stoop/crouch.

Vision

  • •Frequently utilize close vision and the ability to adjust focus

Communication

  • •Frequently required to communicate by talking, hearing, using telephone and e-mail

Genezen's cures value-based competencies

C ommitted to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners

We are committed to being a proactive, collaborative, creative and open-minded pa

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