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| Associate Director OH Open (J#45433) Title: Associate Director Company: Boehringer Ingelheim Description Internal Posting Period: 11/5/11-11/11/11 Boehringer Ingelheim is currently seeking a talented and innovative Associate Director, Process Quality Assurance to join our Quality Assurance department located at our Columbus, OH facility. As the Associate Director, Process Quality Assurance you will be responsible for developing, monitoring and maintaining Quality Assurance standards and processes to ensure compliance with Federal, State, Local, and International regulations associated with cGMP and Quality Systems in BIRI locations (4 Columbus Facilities & Reno) spanning across both the BIRI and RLI businesses. This involves interfacing with government Agencies such as: FDA, EMEA and other international agencies. This position has the authority to stop operations if the operation is in critical violation of a Federal, State, Local and/or International law associated with cGMP or Quality Systems. Responsible for setting standards for work, processes and person behavior. This position ensures alignment to site goals for quality system related activities including, product release to market (domestic and international), 3PM (Third Party Manufacturing -- incoming goods inspection and disposition), and Supplier Quality As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities: - Responsible for overseeing the development, monitoring and maintenance of QA standards and processes to ensure compliance with Federal, State, Local, and International regulations associated with cGMP and Quality Systems. This includes all Columbus Ohio locations & RENO. - Acts as a quality liaison with regulatory authorities during inspections, corporate SQE, and international business partners (Supply chain, logistics, Quality etc.) - Directs the development and maintenance of process quality programs, systems and procedures. - Manages the Supplier Quality Program - Directs and manages the staff of the Process Quality Department. - Develops and administers departmental budget. Required Education & Experience: - B.S./B.A. in science discipline required. - Minimum of 7 years of progressive managerial experience required in a Pharmaceutical (preferred) or related business (chemicals, food, or other similarly-regulated environment). - Demonstrated knowledge of FDA, cGMP , DEA Regulations, EU regulations, and USP. Workman's Compensation Principles and Practices, and employment laws. Emphasis on management of current good manufacturing practices programs. - Demonstrated accomplishments in effectively implementing cGMP and quality system regulations within the pharmaceutical industry. Demonstrated knowledge of Quality Assurance, Production, Laboratories, Regulatory Compliance and Regulatory Affairs functions within a pharmaceutical production environment. - Possess excellent communication skills with the ability to influence/persuade individuals to gain acceptance of an idea or plan. Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust, and build strategic relationships. - Demonstrated knowledge of business and management principles involved in resource allocation, leadership technique, production methods and cGxP requirements, and coordination of people and resources. - Demonstrated understanding of the company vision and demonstrated ability to develop short and long term strategic goals to support the business. - Demonstrated ability to identify complex problems and review related information to develop and evaluate options and implementation solutions. Eligibility Requirements: - Must be legally authorized to work in the United States without restriction. - Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background - Must be willing to take a drug test and post-offer physical (if required) - Must be 18 years of age or older Desired Experience, Skills and Abilities: - Knowledge of financial and budgeting processes preferred for this position. - Experience working at or for Boehringer Ingelheim Roxane Inc. and/or Roxane Laboratories, Inc. -- or another Boehringer Ingelheim company - is preferred, but not required. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. 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