Site Quality Head Athens (Georgia)

Within Janssen Supply Chain, a member of Johnson & Johnson's family of companies, we are recruiting aSite Quality Head Athens (Georgia) to be located in Athens, Georgia.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
This position is head of the Quality functions of the Janssen Pharmaceuticals Quality Operations including Quality Control, Quality Assurance and additional support personnel across the Athens, GA Small Molecule Active Pharmaceutical Ingredient (API) manufacturing site. They are responsible for decisions related to product disposition, adequacy of technical documentation, site readiness, personnel performance, and organizational effectiveness. The position makes quality decisions based upon assessments of compliance risks balanced with the overall business needs. The incumbent crafts a framework within which the organization assesses innovative ways to issue resolution and process improvement. Provides interpretation of policies and regulations to unique site requirements and problems. Acts as quality rep for management initiatives.
Key Responsibilities:
1. Provide direction and oversight of staff responsible for all quality systems. Provide leadership for organizational and technical issues. Drive cross site implementation initiatives. Provide balanced management of quality and compliance risks with business needs.
2. Develops and implements strategy for GMP's compliance for the site. Participate in JSC strategic plan development forums. Assures proper use of compliance and safety MAPs. Assures compliance to all J&J and JSC policies and FDA, ICH and any other regulatory agency requirements for API.
3. Partners with General Manager and Leadership Team to set site vision and strategic direction for the organization and to monitor and drive execution. Assures appropriate site communications.
4. Develops and handles budget, organizational structure and business requirements to accommodate business needs and assure meeting JSC and Quality metrics.
5. Identifies and sponsors PE projects that impact Quality Division and sponsors cross functional business projects and teams, removing barriers to success.
6. Develops direct staff and mentor key individuals in various organizations. Assure that appropriate talent pool is developed to support current and future business needs.
7. Principle work with FDA or other regulatory Health Authorities during inspections and inquiries.
8. Oversight to execution of quality systems such as quality investigations to assess conformance to specifications, company procedures and overall compliance to regulations.
9. Reviews monthly report of site compliance metrics, i.e., rejects, NCRs, First Pass Quality, complaint rate, inspections, headcount, budget, PE plan.
10. Maintain a strong culture of excellence including safety, quality and reliability.
11. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Follows all company and site policies and procedures.
Qualifications
Education:
• University/Bachelors Degree or equivalent required; Degree must be in Science, Pharmaceutical Engineering, Pharmacy, Biochemistry, Microbiology, Biology, Chemistry or Molecular Biology
Experience
Required:
• Minimum of ten to twelve (10-12) years of related work experience
• Experience with Quality Assurance/Quality Control (QA/QC) in the Pharmaceutical industry, solid understanding of regulatory compliance, Quality Systems
• Direct responsibility for QA/QC Managers, Specialists and indirect supervision of supervisors, specialists, & analysts. Approximately 50 employees
• Solid understanding of regulatory compliance, Quality Systems, pharmaceutical methods and procedures and experience with regulatory inspections
• Experience hosting regulatory agency inspections
• Must have excellent organizational, management, and people development skills. Must use interpersonal and collaboration skills to build interdependent partnerships
• Excellent written and oral communication skills
• Must exercise judgment on the resolution of production problems to meet company standards for quality, cost and critical success factors
• Must be able to: travel, work irregular shifts, work extended hours, and might be required to work on holidays and weekends
• The position requires employee to be proficient in the use of MS Office applications: Word, Excel, Power Point, and Internet
Preferred:
• API manufacturing experience is highly preferred
The anticipated base pay range for this position is $142,000 to $230,572.
The anticipated base pay range for this position, in the Bay Area, is $163,000 to $281,750.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.