Director-Bio Quality Control & ComplianceEli Lilly and Company - Fort Dodge, IA
Provide strategic leadership and oversight for quality and compliance initiatives to Elanco for vaccine manufacturing, pharmaceutical manufacturing, and Contract Manufacturers for global product distribution. Responsible for Strategic planning, direction and leadership for all compliance related GXP training (cGMP) at Elanco. Provides strategic direction, leadership and oversight to all Quality & Compliance Functional areas such as but not limited to: Validation, Quality Control, Quality Assurance, Computer System Validation, and Compliance for all products distributed globally from FD site. Provides leadership and direction to Elanco Operations Unit for implementing quality policies, strategic plans, systems and procedures that will assure purity, efficacy, safety and potency of all products manufactured or tested either at Elanco FD facility (vaccine production at Fort Dodge, Iowa) and contract manufacturers. Provides business partnership to various departments within the Elanco such as but not limited to Operations, Marketing, Product Development, Regulatory Affairs, Global and local marketing and R&D for quality issues relating to current products, product launch, and for getting the facilities (Pharmaceutical and Biologicals) registered /approved for worldwide production/distribution. Serves as a focal point for regulatory inspections at the site. Ensures compliance with all regulatory requirements relating to product quality by implementation of relevant regulatory requirements, through education and training of the workforce. Responsible for final regulatory approval at Fort Dodge site for all product categories (i.e. pharmaceuticals and biologicals products) for the following: testing, inspection and release of packaging components, raw materials, labeling, and finished products; product and process validation; quality documentation; contact manufacturing quality activities; and execution of release of export products, recalls, market withdrawals.
Accountabilities: 1-A). Strategic Business Responsibilities: Establishes strategic quality and compliance initiatives for development and production of global products (pharmaceuticals and biological vaccines).
1-I). Successful registration and launch of products in global markets. 2-A). Strategic Quality Development: As part of Plant and Site Lead teams provides input into strategic objectives and direction for improvement to the operations team. 2-I). Strive towards first time quality by cutting down destruction and rework, and site compliance. 3-A). Compliance responsibilities: Functions as a liaison between Corporate QA/ Regulatory Affairs for technical compliance issues pertaining to products sold in the USA and in other countries worldwide. 3-I). Successful resolution of regulatory issues pertaining to registration or other items. 4-A). Responsible for investigating all product quality complaints and adverse events for products sold globally. 4-I). Customer satisfaction and product stewardship. 5-A). Responsible for regulatory inspections. 5-I). No regulatory actions leading to impact of product supply or compliance status. 6-A). Training Function: Directs operations training on relevant regulations. 6-I). Have a workforce well trained in cGMPs. 7-A). Validation responsibilities: Provides leadership and definition to set policies and procedures in place to meet strategic company goals for Development and Production. 7-I). Processes are under control and provide consistent product quality. 8-A). Quality Assurance: Provides leadership and direction to pharmaceutical and biological Quality Assurance functions relating to budget, vendor certifications, specification development and release of components, raw materials and products. 8-I). Assure product quality and compliance to regulatory requirements. 9-A). Quality Control Functions: Provides leadership and direction to pharmaceutical and biological QC for all quality control functions relating to QC budget, stability testing, testing and release of components, raw materials and products. 9-I). Assure testing is done per approved methods and per regulatory requirements in a cost effective way. 10-A). Responsible for maintaining compliance with Elanco quality standards as well as relevant regulatory requirements. 10-I). Keep Elanco Fort Dodge in compliance with corporate and regulatory requirements.
Bachelor's Degree in biochemistry, chemistry, virology, biology or science related field plus 10 years of experience in pharmaceutical and/or vaccine production.
More than 5 years leadership experience in leading employees, projects, leaders and businesses/functions.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Ability to handle assignments with high complexity. Thorough knowledge of cGMP's, 9CFR, EU. EPA, DEA, JMAFF, MCA, Canadian and Australian regulatory requirements. Ability to set up partnership with regulatory authorities to amiably resolve quality & compliance issues. Versatility in conflict resolution, problem solving and working with cross functional teams. Sound business acumen and strategic mindset required.
Responsible for Elanco Animal Health Quality budgeting process and maintaining compliance to budgets. Interface with Elanco US functions such as Regulatory, Marketing, Sales, etc.; Global functions including Global AH Quality And Compliance, and Global Elanco Corporate Quality business units.
Direct Reports: 5-10; Total Reports: >50
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
6 days 21 hours ago
Please review all application instructions before applying.
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.
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