My client a leading Pharmaceutical company now require an Senior
Process Validation Manager - CMO Management .
The Senior Process Validation Manager - CMO Management will represent
my client?s quality organization in the day to day support and
oversight of technical transfer, validation, GMP production and
operations at contract manufacturing and packaging including storage
and distribution for all clinical and commercial products.
This is a permanent role based in Dublin which will come with a strong
salary and benefits package. There are plenty of work from home
flexibility so would also suit someone outside Dublin.
Responsibilities of Senior Process Validation Manager - CMO Management
Lead Validation input for the Biologics programs for my client and CMO
partners. Maintain, manage, and enhance Validation Master Plan for the
Biologics Program Ensure that Validation approach meets commercial and
clinical phase appropriate requirements of US/EU and OUS regulatory
territories Provide expertise and guidance in interpreting existing
and emerging regulations, agency guidelines and internal policies to
assure compliance as relates to Validation Collaborate with
cross-functional teams to provide Validation leadership for Biologic
Drug Substance and Drug Product manufacturing Represent Validation on
Technology Transfer Teams Provide Validation and technical input to
Biologic Drug Substance and Drug Product CMC Product Teams Provide
support to the Senior Director Quality, (Development & External) and
act as designee where required, including CMC support /representation.
Provide Validation representation, guidance, leadership, and direction
to CMO?s, Process Development, and External Operations teams for
both Biologics Drug Substance and Drug Product clinical and
commercial. Provide technical and Validation expertise for product
quality decisions and project team decisions Provide on-going
validation support to External Partners (CMOs) in resolving validation
related issues Evaluate proposed process changes and improvements,
assesses validation impact and provides a ?calibrated? technical
review of change control requests, deviations and Master Batch Record
changes Participate, as a Subject Matter Expert at CMO audits Support
investigations associated with major deviations Author, review and /
or approve documents (SOPs, deviations, CAPAs, change controls, etc.)
Review and approve product lifecycle documentation for biologics
program generated (Development Reports, Risk Assessments, Control
Strategy, Specification and Validation Acceptance Criteria
Documentation) Review and approve Validation documentation generated
by CMOs Provide QA oversight for regulatory submission for Biologic
products Provide SME input for Supplier Quality audits Provide QA
oversight of technology transfer for Biologics products Provide input
into negotiation of quality agreements with Biologic contract
organizations
Responsibilities of Senior Process Validation Manager - CMO Management
Master?s or Bachelor?s degree in biology, biochemical / chemical
engineering, pharmaceutical science, or related field Minimum of 8+
years of progressive industry experience in the area of Biologics
Validation to include a minimum of 4+ years leadership/ management
experience Experience in implementation of Validation Approach to
support production of clinical trial materials for Biologic Drug
Substance and Drug Product manufacturing, technical transfer, and
Validation Experience in supporting regulatory audits (FDA, EMEA,
PMDA, etc.) in support of pre-approval and general inspections
Experience with Validation Oversight experience of Contract
Manufacturing Organizations Must be available for international travel
Follow us on , and
The RFT Group, BioPharmaceutical Division specialize exclusively in
the recruitment of scientists, engineers and executives for the
biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / / **Apply
on the website** or belowJOB DESCRIPTION
My client a leading Pharmaceutical company now require an Senior
Process Validation Manager - CMO Management .
The Senior Process Validation Manager - CMO Management will represent
my client?s quality organization in the day to day support and
oversight of technical transfer, validation, GMP production and
operations at contract manufacturing and packaging including storage
and distribution for all clinical and commercial products.
This is a permanent role based in Dublin which will come with a strong
salary and benefits package. There are plenty of work from home
flexibility so would also suit someone outside Dublin.
Responsibilities of Senior Process Validation Manager - CMO Management
Lead Validation input for the Biologics programs for my client and CMO
partners. Maintain, manage, and enhance Validation Master Plan for the
Biologics Program Ensure that Validation approach meets commercial and
clinical phase appropriate requirements of US/EU and OUS regulatory
territories Provide expertise and guidance in interpreting existing
and emerging regulations, agency guidelines and internal policies to
assure compliance as relates to Validation Collaborate with
cross-functional teams to provide Validation leadership for Biologic
Drug Substance and Drug Product manufacturing Represent Validation on
Technology Transfer Teams Provide Validation and technical input to
Biologic Drug Substance and Drug Product CMC Product Teams Provide
support to the Senior Director Quality, (Development & External) and
act as designee where required, including CMC support /representation.
Provide Validation representation, guidance, leadership, and direction
to CMO?s, Process Development, and External Operations teams for
both Biologics Drug Substance and Drug Product clinical and
commercial. Provide technical and Validation expertise for product
quality decisions and project team decisions Provide on-going
validation support to External Partners (CMOs) in resolving validation
related issues Evaluate proposed process changes and improvements,
assesses validation impact and provides a ?calibrated? technical
review of change control requests, deviations and Master Batch Record
changes Participate, as a Subject Matter Expert at CMO audits Support
investigations associated with major deviations Author, review and /
or approve documents (SOPs, deviations, CAPAs, change controls, etc.)
Review and approve product lifecycle documentation for biologics
program generated (Development Reports, Risk Assessments, Control
Strategy, Specification and Validation Acceptance Criteria
Documentation) Review and approve Validation documentation generated
by CMOs Provide QA oversight for regulatory submission for Biologic
products Provide SME input for Supplier Quality audits Provide QA
oversight of technology transfer for Biologics products Provide input
into negotiation of quality agreements with Biologic contract
organizations
Responsibilities of Senior Process Validation Manager - CMO Management
Master?s or Bachelor?s degree in biology, biochemical / chemical
engineering, pharmaceutical science, or related field Minimum of 8+
years of progressive industry experience in the area of Biologics
Validation to include a minimum of 4+ years leadership/ management
experience Experience in implementation of Validation Approach to
support production of clinical trial materials for Biologic Drug
Substance and Drug Product manufacturing, technical transfer, and
Validation Experience in supporting regulatory audits (FDA, EMEA,
PMDA, etc.) in support of pre-approval and general inspections
Experience with Validation Oversight experience of Contract
Manufacturing Organizations Must be available for international travel
Follow us on , and
The RFT Group, BioPharmaceutical Division specialize exclusively in
the recruitment of scientists, engineers and executives for the
biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / / **Apply
on the website** or below
We need : English (Good)
Type: Permanent
Payment:
Category: Others
