Associate Director, QC Analytical

The Associate Director, QC Analytical is responsible for management of the QC Analytical technology centers of excellence, including hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees laboratory activities related to meeting compliance, schedule adherence, profit plans, and strategy objectives of the company and the department. The Associate Director, QC Analytical identifies operational needs for special projects (new product sub-team, capital projects, etc.) - ensuring site/divisional linkage is achieved. This role identifies and addresses short term, intermediate, and long-term issues in a satisfactory manner, and appropriately resolves conflict and prioritizes work as necessary. The Associate Director, QC Analytical may have managers, supervisors, individual contributors, and hourly support staff reporting to them.

Job Description

Translates company goals into relevant department objectives, focused on assuring the compliance, supply, profit plan, strategy and people/culture objectives are appropriately implemented

Provides logistical and strategic support for achieving department objectives

Represents department for manufacturing, customer, and COE related activities as they relate to resource management

Assures laboratory is capable of delivering to proposed or scoped customer requirements

Assures adherence to headcount and budget plans

Initiates and drives implementation of technology and projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement. Fosters an environment for continuous improvement

Maintains state of inspectional readiness for department

Assures appropriate training requirements are established and that the staff maintains currency to the curricula

Assures team delivers on-time results with right first-time quality

Makes decisions on equipment selection, qualification, maintenance

Assures transferred methods align with department analytical platforms

Provides training and assurance that the transferred methods are fit for purpose and QC personnel are trained to perform the methods consistently

Assures Quality System requirements are delivered according to determined schedules

Fosters a safe working environment through appropriate training and engagement of QC staff

Assures policies, practices, standard work are consistent across the department

Conducts group communication meetings to facilitate project efficiency and/or distribute information

Develops and manages group against KPIs to assure alignment with objectives and manage to target

Participates in the development and management of capital and expense budget

Participates in and develops employee development plans to assure continuity to mid- and long-term succession plans

Manages and develops direct reports from the analytical team

Administers company policies such as time off, shift work, and inclement weather that directly impact employees

Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)

Coaches and guides direct reports to foster professional development

Participates in the recruitment process and retention strategies to attract and retain talent, as needed

Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution

Performs other duties, as assigned

Minimum Requirements:

Bachelor's degree with 11+ years of relevant experience OR

MS degree with 9+ years of relevant experience OR

Ph.D. with 7+ years of relevant experience

8+ years of people management and leadership experience

Experience working in a regulated GMP environment

Experience managing and developing direct reports and teams

Extensive experience with Analytical and Cell-based methods

Preferred Requirements:

8+ years of experience working in a regulated GMP environment

Extensive experience with Drug Product production

Experience working in a contract manufacturing or testing organization

Experience with statistical experimental design and data analysis with JMP software

Working Conditions & Physical Requirements:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in warm/cold environments
• Will work in heights greater than 4 feet.