Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S.
Quidel is searching for a Senior Director, Manufacturing Operations & Site Leader for our manufacturing facility in Athens, OH. As Site Leader, this position provides the vision, strategies, direction, and leadership for all operations at the site. The position coordinates with corporate functions including Human Resources, Finance, Quality, Clinical, etc. to ensure success and health of the overall site, facility, and employees. This includes oversight of the manufacturing, manufacturing facility: both in-bound and out-bound materials and finished goods, as well demand planning to ensure adequate product capacity. This role is responsible for ensuring development and execution of manufacturing activities to meet the established business plan for manufacturing; focus on product, as well as working closely with the Advanced Operations team to assure smooth transition of new products to high volume manufacturing consistent with engineering and quality objectives. Responsibility also includes strategy, capital requirements and maintenance of operation's facilities in support of the annual operating plan.
This position is responsible to develop and achieve Operations KPIs (Safety-People-Quality-Delivery-Cost) by using Daily Management and by engaging/influencing multiple functions (Quality, Engineering, Supply Chain) to drive corrective and preventive actions using effective problem solving. The Senior Director, Manufacturing Operations supports team on the use of best manufacturing practices and create a culture of Continuous Improvement and People development, empowerment and recognition.
Creates and drives site goals and aligns to Quidel's Strategic and Corporate imperatives and goals
Leads the Functional leaders to create a high-performance organization
Accountable for operational and site financials and clearly understands cost structures
Develops and implements business processes to effectively ensure the site operations and internal customer services organizations deliver against their goals and deliver exceptional service levels
Link between Quidel Corporate functions, business units, Sales & Marketing, and site activities
Represents the Site during Executive Management Meetings
Creates a high-performance culture, providing opportunities for all employees to lead
Oversees all operational and internal customer services functions at the site
Develops a quality culture, putting patient safety and product performance first
Ensures operational functions are resourced appropriately to meet their goals
Reviews site Financials on a monthly and quarterly basis with site leadership and determine appropriate action to ensure financial control and success
Supports the evaluation of the capacity, manufacturability, and quality needs for the sites
Works closely with the Commercial organization to ensure site is operating effectively, meeting global customer needs
EDUCATION & EXPERIENCE
MinimumofB.S/B.A.in Engineering ,Business, Life Science or similar field
10 years progressively responsible experience in medical device development and manufacturing with a minimum of 8 years at management level
Minimum of 7years in a pharmaceutical, medical device, or similar manufacturing environment
Previous experience in site, plant, or manufacturing operations, oversight or management
SKILLS & KNOWLEDGE
Change agent with the proven ability to develop a performance driven culture while reducing costs
Hands-on leader, willing to lead "by doing" with strong skills of quickly establishing credibility with teams and colleagues and building strong relationships across a wide spectrum of internal and external parties
Ability to flourish in a fast-paced and dynamic environment with strong results orientation
Ability to collaborate with high performing teams, understanding cross-functional performance drivers and working across levels to achieve corporate goals
Organized and able to handle multiple projects simultaneously with the ability to identify proprietary technology and derive maximum benefit
Ability to resolve issues related to staffing, performance, development, and discipline
Outstanding written and presentation skills with ability to communicate to diverse audiences. Well-developed interpersonal skills, both within the organization and outside of the corporate environment
Managerial Skills-Employee Development/Career Development/Financial Accounting/Project Management
High energy, self-starting professional with strong leadership skills and a high degree of ethics and professionalism.
Experience with direct hands-on interactions with FDA and other regulatory agencies
Demonstrates commitment to the development, implementation and effectiveness of the Quidel Quality Management System per ISO, FDA, and other regulatory agencies
Before you apply, please make sure you share Quidel' s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.