Manager, GMP Operational Manager Analytical QA - Boston, United States - Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, United States

3 weeks ago

Description

Manager,
GMPOperational Manager Analytical QA (Hybrid) page is loaded

Manager,
GMPOperational Manager Analytical QA (Hybrid)

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locations

Boston, MA

time type

Full time

posted on

Posted 8 Days Ago

job requisition id

REQ-21755

Job Description

General Summary:
Th

e

Manager

for Operational
GMPQA

is

a

technical resource in the principles and application of quality assurance and compliance

. The Manager leads the coordination

of

GMP
QA Analytical

activities

in support of

release

of Commercial

Drug Product

.

The

Manager

coordinates

and/

or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Manager

adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. May

manage and develop personnel to support department and functional activities.

This role is a Hybrid Role and holds the requirement to be on site 3 days a week, with the

option

to work remotely 2 days per week.

Key Duties and Responsibilities:
Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions

in support of QA Analytical function.

Responsible for oversight of

analytical activities in support of

release

and validation

activities for

Commercial

Drug

Product (DP)

.

This includes analytical data review and COA generation and approval.

Participates in cross-functional teams as an experienced Quality technical resource

.

Assists

Change Control owners with ensuring compliance

with regulatory and procedural

requirements

.

Assesses and approves change controls for implementation and closure.

Guides and conducts quality investigations /OOS investigations, deviations and reviews corrective action plans for adequacy and compliance.

Lead

s

root-cause analysis and product impact assessment

.

Ensures

appropriate CAPA

actions are

identified

and addressed.

Approves

investigations/CAPAs.

Responsible

of

QA oversight of analytical methods' qualification and transfer, ensuring compliance.

Collects,

maintains

,

and reports

Quality Metrics

.

Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed

.

Work with supplie

r

s to ensure inspection readiness.

Identif

ies

,

facilitate

s

, and/or lead

s

continuous improvement

efforts.

Conducts
GMPdocument review, including procedures, work instructions, specifications, methods, protocols, and method reports

.

Identif

ies

and communicate

s

risks and

assist

s

with risk mitigation

plans

as necessary

.

Provides

support

for

audit or

regulatory inspections

,

a

ssists

in preparation of audit response

s,

as needed

.

May manage personnel and provide oversight of

day-to-day

operations.

May

a

ssists

with workforce planning/resource modeling and to update through forecasting activities

.

Knowledge and Skills:
Good understanding

of both the conceptual and practical application of

cGMPs

in a pharmaceutical setting

.

Understanding

of global
GMPrequirements and support of
GMPmanufacturing

and testing.

Demonstrated ability to evaluate quality matters and solve problems

leveraging

technical experience and advanced judgement to select

appropriate solutions

.

Strong communication

skills (written and verbal) with the ability to

effectively

communicate

with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint

.

Proven experience

to plan an

d

manage

workload

to

achieve

goals

. A

bility to work in a fast-paced environment and meet quality,

accuracy

and timeliness

objectives

.

Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA

.

Strong e

xperience with electronic

quality

management systems

.

Strong knowledge of analytical techniques

(such as HPLC, GC, KF, etc.,).

Strong team

communication

skills with the

Experience using

project management processes / tools to lead meetings,

assist

with project planning, and

facilitate

completion of tasks

.

E

xperience leading complex projects/teams and continuous improvement initiatives within stated

objectives

and timelines

.

Education and Experience:
Bachelor's degree in scientific or allied health field (or equivalent degree)
Typically requires 4 years of experience, or the equivalent combination of education and experience
Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable

guidelines/guidance's

ex

. ICH

, USP, etc.
Advance knowledge of
GMPregulations

, regulatory

requirements

and applicability to duties.
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid:
work remotely up to two days per week;

or select
On-Site
:
work five days per week on-site with ad hoc flexibility.
#LI-Hybrid

Company Information
Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

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Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London.

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Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit

or follow us on

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The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.

By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

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