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Sr. Manager in biotech
Education equivalent to a 4 year college degree, with an emphasis in a technical discipline such as Chemistry, Microbiology, Pharmaceutics or Biochemistry. Additional scientific training M.S., PhD, and/or MBA a plus. * Ten - fifteen years of QA/QC experience in pharmaceutical aseptic manufacturing environment. Sound technical skills including working knowledge of pharmaceutical production, quality assurance, and analytical testing technologies. * In depth knowledge and experience with cGMP/MOH requirements for Pharmaceutcal products in major markets around the world (FDA, TGA, MHRA, etc.). * Experience with and ability to manage and influence regulatory agency personnel at all levels, both in field compliance and agency centers. * In depth knowledge and experience with quality systems, corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing global quality performance in the Pharmaceutcals arena. Essential Skills and Abilities:
* Excellent judgment and decision making capability in the technical and compliance arenas. * Excellent analytical, interpersonal and verbal/written communication skills, with both internal constituencies and external regulatory stakeholders. * Integrity, judgment, and the ability to hold one’s ground under pressure. * Ability to work in a multinational, multicultural and highly matrix environment. * Team player with strong customer orientation. * Ability to travel approximately 20% of the time. * Knowledge and experience in pharmaceutical product documentation procedures with proven ability or project experience in developing systems and business processes to improve overall efficiency and productivity. * Ability to influence individuals that are outside the span of direct control (i.e., influence without authority). * Must have excellent Organizational Skills. Must be detail and quality oriented. * Proficient in computer skills and hands on experience in different computer software such as database management, spreadsheets, project management, presentations word processing flowcharting and/or any other similar type of programming.
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