CHRIS REA

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BIO PH ARM A QU AL IT Y & VAL ID ATION LE AD ER

Biotech and pharmaceutical industry veteran with extensive quality assurance, quality control, validation, and compliance expertise. Immediate value offered:

■ Proven leadership record directing up to 30 employees, leading global cross-functional teams, launching new programs, and effectively managing seven-figure budgets.

■ Familiar with Lean process improvement concepts; record of slashing waste and boosting efficiency.

■ Exceptional in employee development; history of mentoring team members who have advanced.

■ Expertise with regulations for the U.S., Europe, Canada, United Kingdom, and Brazil.

■ Diverse experience spanning pharmaceutical, medical device, biotechnology, and startup companies. PROF ES SIO N AL EXPE RI ENC E

ACTAVIS PHARMACEUTICALS Corona, CA

Director Quality Assurance (April 2011 to October 2014) Lead all quality assurance activities for Corona site’s operations and R&D, with six direct reports and oversight of 54-person department; report to Executive Director of Quality Operations. Actavis is a global pharmaceutical company.

Lead regulatory audits, review ANDA submissions, and manage deviation resolution and CAPA implementation. Review and approve quality agreements for suppliers, vendors, and subsidiaries.

■ Restructured QA organization for greater efficiency, reducing costs by 15% and cycle times by 25%.

■ Implemented electronic document management system that aids in compliance by improving organization and access to policy documents, batch records, test methods, SOPs, and specifications.

■ Led site effort that reduced back orders by $7 million in one month.

■ Prepared international site to meet standards for FDA audit, enabling five new products to be exported to the U.S. for an estimated $100M in annual revenue.

■ Established Talent Management Program to identify and develop future leaders.

■ Designed a global raw material and specification program for international markets, saving $2 million per year.

■ Increased “right-first-time” from 87% to 94% by collaborating with Operations on Lean process improvements to improve clarity of instructions in batch records.

■ Selected to develop Global Continuous Improvement Standards; the standards were approved by management and implemented for about 40 sites worldwide. AMGEN INCORPORATED Thousand Oaks, CA

Director Corporate Quality (Feb. 2008 to March 2011) Promoted to oversee quality policies and systems for all the biotech company’s sites worldwide. Drove seven-figure savings and ensured sustained cGMP and QSR compliance. Defined and implemented standards for equipment qualification, process, and aseptic/sterilization validation. Led geographically dispersed cross-functional teams in development of global and site programs related to cleaning and cleaning validation.

CHRIS REA CONTINUED

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■ Yielded $2M in cost savings after forming and leading global team to define and implement process control standards across four pharmaceutical plants.

■ Tapped to provide interim leadership for the overall validation program and served as interim leader of Validation Forum. Recognized by supervisor and peers for bringing a level of focus and organization to the forum that made it more valuable.

■ Described by colleagues on 360 feedback as a “pragmatic thinker” who “communicates well verbally and in presentations,” is “very easy to work with,” and “has a very deep knowledge of the

[biopharmaceutical] industry and regulatory expectations.”

■ Established program for implementing best practices at all sites and implemented site regulatory inspection recommendations globally enabling rapid transfer of products and knowledge between sites.

Director of Validation (Nov. 2006 to Jan. 2008)

Promoted following successful performance as interim director. Provided strategic leadership to develop site-harmonized validation practices across all Amgen’s facilities and served on teams establishing global quality standards. Oversaw seven-figure budget.

■ Implemented continuous improvement program for the validation program and systems and reviewed it regularly in light of changes in company direction and regulatory environment.

Achieved 40% reduction in repeat testing in qualification protocols after championing a robust commissioning program that ensured equipment was ready for qualification.

■ Coached and mentored three team members who advanced into leadership roles.

■ Led transition of Thousand Oaks site from commercial manufacturing to clinical manufacturing, and developed five-year plan for the site ensuring clinical trial product supply.

■ Established SLAs with Quality Assurance, Manufacturing, and Process Development. Interim Director of Validation (Feb. 2006 to Feb. 2007) Given additional responsibility of overseeing validation for Abgenix before and after Amgen’s acquisition of the company, in addition to regular validation management duties for Thousand Oaks site. Created vision and mission for site validation team.

■ Led Abgenix Fremont site’s validation, manufacturing, and process development organizations in completion of the IQs, OQs, cleaning, and process validations for Pre-Approval Inspection (PAI); led site through three successful PAIs.

■ Collaborated on team that spearheaded integration of Abgenix site into Amgen’s culture and systems.

■ Trained staff to successfully present validation protocols to regulatory agencies.

■ Strong performance resulted in being selected as director on permanent basis. Senior Manager, Validation (Nov. 2002 to Nov. 2006) Joined biotechnology / biopharmaceutical company in role managing quality control and validation for bulk and aseptic manufacturing processes in Thousand Oaks and a distribution center in Kentucky. Spearheaded several new programs, including a non-conformance and corrective action program, a small molecule validation program, a validation program for commercial off-the-shelf instruments, and a risk- based validation program.

■ Led the validation of two major facility upgrades.

■ Developed metrics program enabling quick determination and correction of validation issues. CHRIS REA CONTINUED

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PROCTER & GAMBLE PHARMACEUTICALS / OSG NORWICH PHARMACEUTICALS Norwich, NY Department Manager, Compliance & Validation (Feb. 1998 to Nov. 2002) Led validation and compliance programs and training systems, continuing in same role after the P&G plant was acquired by OSG Inc. in June 2001. Led 15 employees. Developed department business plan and goals. Managed multi-million dollar budget. Managed site’s internal audit program and co-hosted cGMP and PAI audits.

■ Assembled and led global team that successfully completed validation of SAP.

■ Developed global CFR Part 11 training program and implemented it for hundreds of employees, personally conducting training for most sites.

■ Mentored and developed team member who rose to high level at P&G.

■ Joined company as Validation Manager and immediately improved validation program, enabling quicker and successful PAIs for three new drugs.

■ Promoted from Validation Manager to Department Manager after demonstrating leadership abilities. plan

EDUC AT I ON & TR AIN IN G

Bachelor of Science, Chemistry

State University College of New York at Fredonia

Professional Development: In-House Management Training at Amgen and P&G Class topics included: Developing a High-Performing Organization, Managing in a Changing Environment, Listening Skills, Relationship Building

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