QUALITY DIRECTOR / TECHNICAL DIRECTOR

Well known, established?specialty consumer products manufacturer with national presence is?searching for a talented, growth?oriented, hands-on?Quality Director with strengths?in providing proactive leadership for all Quality and Technical related functions.??

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The?Quality Director ensures?plant compliance with all regulatory and customer requirements, directs, coaches and guides the activities of other?plant management team members and subordinates and is?the primary contact for customer audits and commitment initiatives. Critical functions within the scope of responsibility are: Aligning procedures with cGMPs, Development of SOP?s and Change Control procedures; develops product exception release policy and processes; performs critical review of manuals and disseminates information appropriately while driving change initiatives.

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This position reports?to the General Manager with additional accountability to?VP Quality, and has overall responsibility for assuring product quality in addition to the following:Recommends Process Improvements to Formulations and manufacturing procedures, will work closely with QA regarding process deviations and validations; partners with Supply Operations on new materials/supplier sourcing; and supports Regulatory requirements with appropriate filing. Will?ensure compliance with all Quality, Regulatory, Health and Safety and Environmental guidelines, policies and procedures, and ensures that regulatory requirements are met while keeping abreast of new GMP requirements. Leads all customer relationships on Quality and Technical Subjects, negotiates and maintain agreements with customers and ensures customer satisfaction Change Management - leads quality improvement initiatives and training program initiatives on cGMP? Training and mentoring of the Quality and additional Plant Management team members. Promotes continuous quality improvement via a strong background with cGMP?s, and Lean principles Experience in production of Pharmaceutical/Food/medical device manufacturing, and some experience in product process and development ?Manages Quality Assurance Systems related to Analytical and Micro Laboratories: Raw Material, In process bulk and finished goods analyses, production line QC/QA activities, specification management systems, validations, change control, training and CAPA programs.

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To qualify for this position,?background should include: Minimum of 6 years of progressive experience in Quality Assurance leadership role in consumer packaged goods or personal care products in Technical Services and Engineering / OR Quality Management in a packaging / filling environment Bachelor?s Degree.? Chemistry, Chemical Engineering, Biology or Microbiology preferred. Will consider equivalent combination of education and experience Hands-on Manager with a sense of urgency, ability to manage and perform under pressure with demonstrated ability in leading and managing multiple projects on time CGMP Auditing experience and certifications Experience in OTC pharmaceutical experience highly preferred ? Experience with FDA Audit / investigations a significant plus Expertise in the principles and practice of cGMPs and associated regulatory considerations in HBA / OTC pharmaceutical environment?? Knowledge/ experience with the Pharmaceutical Industry is a plus but not required.? ASQ Certification such as CQA, CQE, CQM Supervisory experience

Excellent benefits and highly competitive compensation are available with this position.?Please email your resume in MS Word for immediate consideration.? All inquiries are confidential.