[AIChE] Fwd: AIChE - Job opportunities

[Owen Jappen]

Seniors!

See below!



*Job Opportunities:*



*SR. MANAGER REGULATORY COMPLIANCE*

* *

Our client is recognized globally for their unparalleled semi-solid and
liquid technical expertise.  They are the first choice for semi-solid and
liquid development and manufacturing services for the world’s leading
pharmaceutical, biotechnology, and healthcare companies.



With four cGMP facilities and over a million square feet of state-of–the-art
manufacturing, packaging, and distribution space, our client offers full
service outsourcing solutions including stand alone development, site
transfers, turnkey production, packaging, and worldwide distribution.
Quality is a culture — not a task. This philosophy, which dates back over 60
years, is shared by over 1,000 employees.



Provide team leadership to support Regulatory & Compliance activities for
multiple manufacturing sites.  Develop and authorize the implementation of
site policies and procedures (SOPs) to assure compliance with government
requirements (FDA, EU, MHRA, etc.), and corporate policies.  Work with
Quality Staff to assure alignment of policies and procedures between and
within sites.  Represent client with customers and regulatory agencies.

RESPONSIBILITES



·         Site Compliance: ensure sites are compliant with applicable
quality and regulatory requirements for cGMP, QSR, and cGLP regulations.

·         Inspections and Audits:  Manage FDA, MHRA, (and other regulatory
bodies) and Customer Audits.  This includes preparation for and managing
responses to FDA and client audit reports, managing

·         CAPA, and tracking other regulatory commitments

·         Regulatory Expertise: Develop and maintain regulatory expertise
and knowledge of industry trends.  Advise the organization in matters
relating to cGMP, QSR, NDA/OTC requirements, and other regulatory policies
and changes being implemented by regulatory agencies.

·         Vendor Audits: In conjunction with Purchasing and QC, identify and
manage vendor and service provider audits.

·         Quality Agreements: Develops standard quality/technical agreements
and manages these agreements in conjunction with customers, vendor and
contract lab facilities.

·         Budgets: Develop and manage budgets for the Compliance Team in
support of business initiatives and strategies.

·         Customer Interface:  Develop and maintain relationships with
Customers for current and future products.





REQUIREMENTS



·         Proven experience as a Sr. Manager or Manager of Regulatory
Compliance for a Pharmaceutical, Biotech or Medical Device Manufacturer.

·         Bachelor’s Degree

·         Strong leadership, communication and organization skills



A VERY COMPETITIVE COMPENSATION, BENEFIT AND RELOCATION PACKAGE IS OFFERED.
TEXAS DOESN'T HAVE STATE INCOME TAX AND THE COST OF LIVING COMPARISON
BETWEEN HERE AND JUST ABOUT ANYWHERE ELSE IN NORTH AMERICA IS DRAMATICALLY
LOWER.   PLUS THE QUALITY OF LIFE AND PUBLIC SCHOOLS ARE EXCELLENT.



TO APPLY:



Attach your resume to an email addressed esearch at mchsi.com. Include your
daytime contact number.



*PROJECT MANAGER*



Our client is a Pharmaceutical Company recognized globally for their
unparalleled development and manufacturing services for the world’s leading
pharmaceutical, biotechnology, and healthcare companies.

With four cGMP facilities and over a million square feet of state-of–the-art
manufacturing, packaging, and distribution space, our client offers full
service outsourcing solutions including stand alone development, site
transfers, turnkey production, packaging, and worldwide distribution.
Quality is a culture — not a task. This philosophy, which dates back over 60
years, is shared by over 1,000 employees.



 PROJECT MANAGER, Pharmaceutical Manufacturing



The Project Manager will manage clients' drug development projects from
inception to commercialization. These complex portfolio projects will have
total annual development revenue potential in the $2MM-4MM range.

* *

RESPONSIBILITIES



·         Manage clients' drug development projects from awarding of
business through commercial process validation.

·         Assist the Business Development Manager in closing new business.

·         Lead and motivate a cross-functional project team for all assigned
projects in collaboration with the relevant managers.  Coordinate the
activities of the clinical monitoring, data management and other personnel
assigned to the project team.

·         Identify and lead efforts to improve processes/systems.

·         Determine the timelines, SOPs/procedures to be followed, billing
milestones, documentation required and establish reporting needs at the
start of the project.

·         Ensure the quality of all services outlined in the contract and
perform quality control checks for these services (e.g., review of approval
of data validation specifications, review and approval of study protocols
etc) and adherence to SOPs and Guidelines.

·         Self-develop to be able to move into position of greater
responsibility within 2-3 years as opportunities occur.

 REQUIREMENTS

·         Proven experience as a Project Manager, Drug Development for
a Pharmaceutical company or CRO (Not Computer Technology)

·         PMP Certified or have started to obtain

·         Bachelors Degree

·         Strong communication, organization and team orientated skills





A VERY COMPETITIVE COMPENSATION, BENEFIT AND RELOCATION PACKAGE IS OFFERED.
TEXAS DOESN'T HAVE STATE INCOME TAX AND THE COST OF LIVING COMPARISON
BETWEEN HERE AND JUST ABOUT ANYWHERE ELSE IN NORTH AMERICA IS DRAMATICALLY
LOWER.   PLUS THE QUALITY OF LIFE AND PUBLIC SCHOOLS ARE EXCELLENT.



To Apply



Attach your resume to an email addressed karel.mri at mchsi.com and include a
daytime contact number.
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