Seniors!<br><br>See below!<div><br><div class="gmail_quote"><div style="font-family:Arial;color:#000000;font-size:10pt"><font color="#000000" size="2" face="Arial"><div>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:8.5pt"> </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><b><u><span style="color:black;font-size:16pt">Job
Opportunities:</span></u></b></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:8.5pt"> </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><b><span style="color:black;font-size:10pt">SR.
MANAGER REGULATORY COMPLIANCE</span></b></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><b><span style="color:black;font-size:10pt"> </span></b></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">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.</span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">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. </span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="font-size:10pt"> </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="font-size:10pt">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.
</span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="font-size:10pt">RESPONSIBILITES</span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="font-size:10pt"> </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Site Compliance:
ensure sites are compliant with applicable quality and regulatory requirements
for cGMP, QSR, and cGLP regulations.<span style="color:black"></span></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">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</span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">CAPA, and tracking
other regulatory commitments</span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">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.<span style="color:black"></span></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Vendor Audits: In
conjunction with Purchasing and QC, identify and manage vendor and service
provider audits. </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Quality Agreements:
Develops standard quality/technical agreements and manages these agreements in
conjunction with customers, vendor and contract lab facilities.<span style="color:black"></span></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Budgets: Develop
and manage budgets for the Compliance Team in support of business initiatives
and strategies.</span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Customer
Interface: Develop and maintain relationships with Customers for current
and future products.</span></p>
<p style="margin:0in 0in 0pt 0.25in" class="MsoNormal"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.25in" class="MsoNormal"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.25in" class="MsoNormal"><span style="color:black;font-size:10pt">REQUIREMENTS</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.25in" class="MsoNormal"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in" class="MsoNormal"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="color:black;font-size:10pt">Proven
experience as a Sr. Manager or Manager of Regulatory Compliance for a
Pharmaceutical, Biotech or Medical Device Manufacturer.</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in" class="MsoNormal"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="color:black;font-size:10pt">Bachelor’s
Degree</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in" class="MsoNormal"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="color:black;font-size:10pt">Strong
leadership, communication and organization skills</span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 0.5in"><span style="color:black;font-size:10pt"> </span><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">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.
</span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt 1in"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">TO
APPLY:</span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">Attach
your resume to an email addressed <a href="mailto:esearch@mchsi.com" target="_blank">esearch@mchsi.com</a>. Include your daytime
contact number.</span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="font-size:10pt"> </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><b><span style="color:black;font-size:10pt">PROJECT
MANAGER</span></b></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt"> </span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">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.</span><span style="font-size:10pt"></span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="color:black;font-size:10pt">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. </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt"><span style="font-size:10pt"> </span></p>
<p style="margin:0in 0in 0pt"><span style="color:black;font-size:10pt"> PROJECT
MANAGER, Pharmaceutical Manufacturing </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt"><span style="color:black;font-size:10pt">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.</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt"><b><span style="color:black;font-size:10pt"> </span></b><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt"><span style="color:black;font-size:10pt">RESPONSIBILITIES</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt"><span style="color:black;font-size:10pt"> </span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Manage clients'
drug development projects from awarding of business through commercial process
validation.</span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Assist the Business
Development Manager in closing new business.</span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">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.</span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="color:black;font-size:10pt">Identify
and lead efforts to improve processes/systems.</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Determine the
timelines, SOPs/procedures to be followed, billing milestones, documentation
required and establish reporting needs at the start of the
project.</span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="color:black;font-size:10pt">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.</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="color:black;font-size:10pt">Self-develop
to be able to move into position of greater responsibility within 2-3 years as
opportunities occur.</span><span style="font-size:10pt"></span></p>
<p><span style="font-size:10pt"> <span style="color:black">REQUIREMENTS</span></span></p>
<p style="margin:0in 0in 0pt 39pt"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Proven experience
as a Project Manager, Drug Development for a Pharmaceutical
company or CRO (Not Computer Technology)</span></p>
<p style="margin:0in 0in 0pt 39pt"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">PMP Certified or
have started to obtain</span></p>
<p style="margin:0in 0in 0pt 39pt"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Bachelors
Degree</span></p>
<p style="margin:0in 0in 0pt 39pt"><span style="font-family:Symbol;font-size:10pt"><span>·<span style="font:7pt 'Times New Roman'">
</span></span></span><span style="font-size:10pt">Strong
communication, organization and team orientated skills</span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="color:black;font-size:10pt">
</span><span style="font-size:10pt"></span></p>
<p style="margin:0in 0in 0pt 0.5in"><span style="font-size:10pt"> </span></p>
<p style="margin:0in 0in 0pt"><span style="font-size:10pt">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. </span></p>
<p style="margin:0in 0in 0pt"><span style="font-size:10pt"> </span></p>
<p style="margin:0in 0in 0pt" class="MsoNormal"><span style="font-size:10pt">To
Apply</span></p>
<p style="margin:0in 0in 0pt" class="MsoNormal"><span style="font-size:10pt"> </span></p>
<p style="margin:0in 0in 0pt" class="MsoNormal"><span style="font-size:10pt">Attach your resume
to an email addressed <a href="mailto:karel.mri@mchsi.com" target="_blank">karel.mri@mchsi.com</a> and include a daytime
contact number.</span></p>
<p style="line-height:18pt;margin:0in 0in 0pt"><span style="font-size:10pt"> </span></p></div></font></div>
</div><br></div>