Senior Manager, QA Laboratory Compliance - Baltimore, United States - Novavax

Description

Senior Manager, QA Laboratory Compliance
See your future through a different lens
Be Novalutionary TM
If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:
NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases.

We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS.

Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.

Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Job Summary
Weare seeking a

Sr. Manager

,

Quality Assurance

tojoin our

Laboratory Compliance

organization

inGaithersburg,MD.

The candidate will

be responsible for

leading a team in

providing quality oversight

in support of

batch related,

stability

o

perations

,

health agency responses

and technology transfer

testi

n

g

and

ensuring

compliance in

Novavax's

GxP

laboratories

in

the

U.S.

The candidate will also

be responsible for

providing quality oversight of testing performed by contract testing laboratories.

This position reports

directly

to the

Director

,

Laboratory

Compliance

.

Essential Functions
Strong leadership and managerial skills

, with the ability to effectively mentor

and develop team members

.
Stron

g

experien

ce with QMS related

to

robust

investigation

s

of

nonconformances

,

out of specification test results

and change control

s

.
Monitor

the metrics for laboratory compliance team

and

QA initiatives and performance improvements.
Ensure the effective management of resources and provide the

appropriate level

of oversight to progress work to meet organizational timelines.
Proven experience

leading successful regulatory inspections and audits.
Provide

Quality

oversight

for various regulatory submission deliverables and Health authority responses.
Partners with Q

uality

C

ontrol

and A

nalytical

D

evelopment

functions at Novavax

in

support

of

method qualifications,

m

ethod

v

alidations

/verifications

,

m

ethod transfer

,

specifications,

batch release, and stability

program

activities

.
Ability to manage multiple

projects simultaneously and prioritize effectively in a fast-paced

environment.
Required Knowledge, Skills, and Abilities
The ability to effectively build and

maintain

relationships across the organization to effectively solve problems.
The ability to

influence,

enable

,

and drive change

as applicable with

both

internal and external customers.
The ability to produce high-quality work on complex problems with cross-functional and global impact; to take ownership of quality considerations and standards across the team's work product

.
Excellent communication

, interpersonal

and

problem-solving

skills

.
Cer

tification in quality management or regulatory affairs

(

e.g.

ASQ, RAPS) is a plus

.
Manage and mentor QA team members, fostering a culture of continuous improvement and accountability.
Education, Experience, Licenses & Certifications
B

achelor's degree in a scientific discipline;

Master's

degree or higher preferred
8

• years' experience in

GMP biologics and/or vaccine

,

pharmaceutical

manufacturing
5

years

of leadership

experience

in

Quality Assuranc

e

.
Extensive knowledge of U.S., EU, and ICH regulations and guidance's related to

GxP

activities

,

with particular focus on the Laboratory

Operations

.
This position may require periodic weekend/evening work.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity

Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer.

Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

Provide your interests and experience, and we'll keep you informed of relevant opportunities, news, and events with Novavax via email and text message updates.

#J-18808-Ljbffr