Job Details: QA Senior Specialist, Actives and Intermediates


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QA Senior Specialist, Actives and Intermediates


Bristol-Myers Squibb is a global Biopharma company committed to a
single mission: to discover, develop, and deliver innovative medicines
focused on helping millions of patients around the world in disease
areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide
them with a work environment that places a premium on diversity,
integrity, collaboration and personal development. Through a culture
of inclusion, we create a better, more productive work environment. We
believe that the diverse experiences and perspectives of all our
employees help to drive innovation and transformative business
results.

BMS has one of the most reliable supply networks and our clinical
operations program is among the best and busiest anywhere. We are a
company that is forward thinking, a company in which diversity and
inclusion are at the forefront of how we view our talent and how we
work. Our science is second to none and the transformation work
underway will enable us to continue to lead our peer group.

Bristol-Myers Squibb External Manufacturing is looking to recruit a
permanent QA SENIOR SPECIALIST , ACTIVES & INTERMEDIATES based in
Ireland. The role will be responsible for the quality oversight of our
contract manufacturers (CMOs), supplying various APIs, chemical
intermediates and starting materials to the Global market. The QA
Senior Specialist, Actives & Intermediates will provide Quality
Operational support and will report directly to the Quality Operations
Manager .

KEY RESPONSIBILITIES WILL INCLUDE, BUT NOT LIMITED TO:

* Proactively manage contract manufacturer relationships from a
quality and compliance perspective. Build strong effective working
relationships with CMO&#**Apply on the website**;s
* Develop and manage the quality events, change control and market
complaints programs in respect of contract manufacturers. Ensure an
effective deviation management system is in place to deal with vendor
non-conformances from third party suppliers. Review process validation
protocols and reports and also process verification/campaign reports
for CMO&#**Apply on the website**;s where relevant.
* Ensure qbD principles are implemented for all new products at
CMO&#**Apply on the website**;s. Review and approval of process risk
assessment, process verification reports for CMO&#**Apply on the
website**;s for intermediates and API. Support pre-approval
inspections
* Manage all activities associated with vendor approvals
* Provide Technical Quality /compliance subject matter expertise to
the wider Supplier Relationship Management, Global Procurement, Supply
Chain and MT teams in support of new projects, technical transfers
programs, supplier selection programs, investigations, validation
programs etc.
* Provide the requisite quality support to Global BMS functional
groups such as Global Regulatory/CMC and the local country based
regulatory managers in support of regulatory filings, product
renewals, regulatory agency questions etc.
* Manage the quality metrics programs in relation to CMO
performance.
* Serve as the Quality Operations leader in Technical Transfer
projects and Manufacturing Launch Teams (MLTs) relating to Third
Parties.
* Prepare, negotiate and approve Quality Agreements with
CMO&#**Apply on the website**;s
* Review and approve the Annual Product Reviews submitted by the
CMO&#**Apply on the website**;s Support the Global BMS external
auditing program by participation in audits of Third Parties as
requested.
* Mange information/provide information for quality council meeting
* Assess and implement corporate policies and directives
* Liaise with auditors of external vendors and suppliers. Review
vendor audits to identify trends

?

QUALIFICATIONS AND EXPERIENCE REQUIRED:

* The successful candidate will have 3 YEARS OF API (ACTIVE
PHARMACEUTICAL INGREDIENTS) EXPERIENCE and 3 YEARS OF EXPERIENCE AT
QUALITY OPERATIONS SITE to efficiently support the selection of new
contract manufacturing partners and suppliers.
* In addition the candidate must be competent to work across
cultures and geographies in an integrative manner.
* A BSc Chemistry or other relevant scientific BSc, in addition to a
minimum of five years of experience in a GMP environment, having spent
a minimum of five years in a QA position.
* Excellent communication skills and relationship building expertise
with both suppliers and business partners.
* Goal-oriented approach to project management coupled with the
ability to manage simultaneous projects.
* Excellent organisational and administration skills are required in
addition to strong interpersonal skills.
* Thorough knowledge and understanding of Regulatory requirements
and filing processes is required.
* Operational Excellence qualifications are an advantage.
* Confident management of internal and external stakeholder
relationships
* Employees are expected to display the BMS Biopharma Behaviours,
which enable them to be successful and perform at their highest level.
The BMS Behaviours are: Passion, Innovation, Accountability and Speed.

* In the absence of the Associate Director, Quality Operations
Global API, the Quality Operations Senior Specialist can act as
designee, review and approval of change controls, signatory on GMP
documentation, representation at meeting.

NOTE: Travel will be required on a routine basis as part of this role
(approx. **Apply on the website**%).

Employees are expected to display the BMS Biopharma Behaviours, which
enable them to be successful and perform at their highest level. The
BMS Behaviours are: Passion, Innovation, Accountability and Speed.

* PASSION : We pursue excellence to help patients prevail.

* INNOVATION: We embrace new ideas .

* ACCOUNTABILITY: We own our outcomes and the outcomes of others.

* SPEED: We act with urgency and agility.

WHY SHOULD YOU APPLY:

* You will help patients in their fight against serious diseases
* You willbe part ofa company that encourages excellence and
innovation, respects diversity, develops leaders and values its
employees.
* You&#**Apply on the website**;ll get a competitive salary and a
great benefits package including an annual bonus, pension
contribution, family health insurance, **Apply on the website**.5 days
annual leave plus 3 Company days, life assurance and gain-sharing
bonus.

Bristol-Myers Squibb recognizes the importance of balance and
flexibility in our work environment. We offer a wide variety of
competitive benefits, services and programs that provide our employees
the resources to pursue their goals, both at work and in their
personal lives.



Bristol-Myers Squibb is a global Biopharma company committed to a
single mission: to discover, develop, and deliver innovative medicines
focused on helping millions of patients around the world in disease
areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide
them with a work environment that places a premium on diversity,
integrity, collaboration and personal development. Through a culture
of inclusion, we create a better, more productive work environment. We
believe that the diverse experiences and perspectives of all our
employees help to drive innovation and transformative business
results.

BMS has one of the most reliable supply networks and our clinical
operations program is among the best and busiest anywhere. We are a
company that is forward thinking, a company in which diversity and
inclusion are at the forefront of how we view our talent and how we
work. Our science is second to none and the transformation work
underway will enable us to continue to lead our peer group.

Bristol-Myers Squibb External Manufacturing is looking to recruit a
permanent QA SENIOR SPECIALIST , ACTIVES & INTERMEDIATES based in
Ireland. The role will be responsible for the quality oversight of our
contract manufacturers (CMOs), supplying various APIs, chemical
intermediates and starting materials to the Global market. The QA
Senior Specialist, Actives & Intermediates will provide Quality
Operational support and will report directly to the Quality Operations
Manager .

KEY RESPONSIBILITIES WILL INCLUDE, BUT NOT LIMITED TO:

* Proactively manage contract manufacturer relationships from a
quality and compliance perspective. Build strong effective working
relationships with CMO&#**Apply on the website**;s
* Develop and manage the quality events, change control and market
complaints programs in respect of contract manufacturers. Ensure an
effective deviation management system is in place to deal with vendor
non-conformances from third party suppliers. Review process validation
protocols and reports and also process verification/campaign reports
for CMO&#**Apply on the website**;s where relevant.
* Ensure qbD principles are implemented for all new products at
CMO&#**Apply on the website**;s. Review and approval of process risk
assessment, process verification reports for CMO&#**Apply on the
website**;s for intermediates and API. Support pre-approval
inspections
* Manage all activities associated with vendor approvals
* Provide Technical Quality /compliance subject matter expertise to
the wider Supplier Relationship Management, Global Procurement, Supply
Chain and MT teams in support of new projects, technical transfers
programs, supplier selection programs, investigations, validation
programs etc.
* Provide the requisite quality support to Global BMS functional
groups such as Global Regulatory/CMC and the local country based
regulatory managers in support of regulatory filings, product
renewals, regulatory agency questions etc.
* Manage the quality metrics programs in relation to CMO
performance.
* Serve as the Quality Operations leader in Technical Transfer
projects and Manufacturing Launch Teams (MLTs) relating to Third
Parties.
* Prepare, negotiate and approve Quality Agreements with
CMO&#**Apply on the website**;s
* Review and approve the Annual Product Reviews submitted by the
CMO&#**Apply on the website**;s Support the Global BMS external
auditing program by participation in audits of Third Parties as
requested.
* Mange information/provide information for quality council meeting
* Assess and implement corporate policies and directives
* Liaise with auditors of external vendors and suppliers. Review
vendor audits to identify trends

?

QUALIFICATIONS AND EXPERIENCE REQUIRED:

* The successful candidate will have 3 YEARS OF API (ACTIVE
PHARMACEUTICAL INGREDIENTS) EXPERIENCE and 3 YEARS OF EXPERIENCE AT
QUALITY OPERATIONS SITE to efficiently support the selection of new
contract manufacturing partners and suppliers.
* In addition the candidate must be competent to work across
cultures and geographies in an integrative manner.
* A BSc Chemistry or other relevant scientific BSc, in addition to a
minimum of five years of experience in a GMP environment, having spent
a minimum of five years in a QA position.
* Excellent communication skills and relationship building expertise
with both suppliers and business partners.
* Goal-oriented approach to project management coupled with the
ability to manage simultaneous projects.
* Excellent organisational and administration skills are required in
addition to strong interpersonal skills.
* Thorough knowledge and understanding of Regulatory requirements
and filing processes is required.
* Operational Excellence qualifications are an advantage.
* Confident management of internal and external stakeholder
relationships
* Employees are expected to display the BMS Biopharma Behaviours,
which enable them to be successful and perform at their highest level.
The BMS Behaviours are: Passion, Innovation, Accountability and Speed.

* In the absence of the Associate Director, Quality Operations
Global API, the Quality Operations Senior Specialist can act as
designee, review and approval of change controls, signatory on GMP
documentation, representation at meeting.

NOTE: Travel will be required on a routine basis as part of this role
(approx. **Apply on the website**%).

Employees are expected to display the BMS Biopharma Behaviours, which
enable them to be successful and perform at their highest level. The
BMS Behaviours are: Passion, Innovation, Accountability and Speed.

* PASSION : We pursue excellence to help patients prevail.

* INNOVATION: We embrace new ideas .

* ACCOUNTABILITY: We own our outcomes and the outcomes of others.

* SPEED: We act with urgency and agility.

WHY SHOULD YOU APPLY:

* You will help patients in their fight against serious diseases
* You willbe part ofa company that encourages excellence and
innovation, respects diversity, develops leaders and values its
employees.
* You&#**Apply on the website**;ll get a competitive salary and a
great benefits package including an annual bonus, pension
contribution, family health insurance, **Apply on the website**.5 days
annual leave plus 3 Company days, life assurance and gain-sharing
bonus.

Bristol-Myers Squibb recognizes the importance of balance and
flexibility in our work environment. We offer a wide variety of
competitive benefits, services and programs that provide our employees
the resources to pursue their goals, both at work and in their
personal lives.



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Type: Permanent
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Category: Others

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