Director, Quality Control Analytical

Catalent • Harmans, MD

2d • Onsite

About The Position

Director, Quality Control Analytical Position Summary 100% on-site Catalent, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Director of QC Analytical is responsible for overseeing the Quality Control (QC) strategies and operations, including but not limited to the testing function in support of raw materials, in-process and finished products of Phase I-III and commercial programs. The Director, QC Analytical assures compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The Director identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Director keeps laboratory management informed of all departmental activities and product related events. The Director, Quality Control Analytical will report to the Head of Quality. The Role Accountable for all activities within the QC Analytical department. Leads the team on the strategies for daily activities of QC Analytical and QC Support Services and assures that job activity deadlines are met on a timely basis. Hires and oversees the training of QC department personnel. Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly. Interacts and communicates with customers to assure expectations are established, agreed to, and achieved. Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer. Identify, maintain, and report functional KPIs to site management. Assures execution of testing programs to assess the quality of raw materials, components, in-process and finished goods, and effectiveness of production processes. Works with leaders to generate new/revise Standard Operating Procedures for analytical test procedures. Other duties as assigned.

Requirements

• Bachelor’s degree required and 10+ years of relevant experience with 8+years of direct management experience.
• Experience in Analytical testing required.
• Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance’s (US and EU).
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.
• Creative individual with excellent problem solving and trouble shooting skills and ability to work effectively under pressure to meet deadlines.

Nice To Haves

• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

• Accountable for all activities within the QC Analytical department.
• Leads the team on the strategies for daily activities of QC Analytical and QC Support Services and assures that job activity deadlines are met on a timely basis.
• Hires and oversees the training of QC department personnel.
• Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly.
• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
• Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
• Identify, maintain, and report functional KPIs to site management.
• Assures execution of testing programs to assess the quality of raw materials, components, in-process and finished goods, and effectiveness of production processes.
• Works with leaders to generate new/revise Standard Operating Procedures for analytical test procedures.
• Other duties as assigned.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment.
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees