GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

• Relocation assistance is NOT provided.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

EDUCATION:

Bachelor’s Degree required in a scientific or related field highly preferred.

EXPERIENCE:

• 7+ years of relevant experience required. Preferably in the pharmaceutical industry that includes 5+ years supervisory experience.
• Project Management skills desired.
• Superior cGMP experience and leadership required.
• Deep knowledge of cGMPs and pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs.
• Advanced problem-solving skills and comfortable working directly with our valued customers to identify solutions.
• Strong communication, persuasion, and presentation skills.
• Advanced change management skills are vital.
• Must be able to interact with and influence the most senior levels of the organization.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

• Manage the quality on the floor team supporting quality oversight of the operational areas within Thermo Fisher Scientific.
• Review and approve quality records such as investigations, protocols, and procedures.
• Handle the functions and staff, to assure the products, processes, and records align with company specifications, legal agreements, and applicable regulations as a requirement for release to license holder and/or market.
• Provide tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules.
• Provide direct supervision and may assist with the work as demands dictate.
• Provide leadership to assigned staff by performing the following: • Leading organizational change. • Developing and empowering staff. • Encouraging relationships. • Putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals. • Building effective teams that apply their diverse skills and perspectives to achieve common goals. • Driving engagement and crafting a climate where staff is motivated to do their best.
• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems.
• Ensure quality of methods, processes, and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
• Follow all job-related safety and other training requirements in a timely manner.
• Support systems and new product introduction as a technical resource by providing assessment technical expertise, problem solving, and strategies for problem prevention.
• Develop strategies and priorities to assure future success of the Company.
• Conduct quality risk assessments, and takes appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety, and business risks.
• Manage resources by budgeting for and assuring availability of staff to meet business needs.
• Maintain current knowledge of emerging trends and technologies.
• Ensure staff has performance plans with metrics in place.
• Review are conducted twice a year (mid-year and annually).
• Identify and manage performance/team issues.
• Provide training and/or opportunities for career development of staff.