Manager, QMS Record Management (Contractor)

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Requirements:

• Bachelor's or Master's Degree in a scientific or technical discipline.
• 7+ years of relevant Record Management experience in a biotech/pharmaceutical setting.
• Hands-on experience with controlled/regulated record lifecycle management.
• Strong project management skills and ability to manage multiple projects.
• In-depth knowledge of relevant regulations like FDA 21 CFR and ISO 9001.
• Excellent cross-functional collaboration and communication skills.
• Experience managing audits and regulatory inspections.
• Demonstrated analytical and problem-solving abilities.
• Familiarity with Content Management Systems and similar business tools.
• Ability to thrive in a dynamic, fast-growing biotech environment.

Responsibilities:

• Build world-class infrastructure to enable the management of records across the enterprise.
• Lead the implementation, ownership, oversight, maintenance, and execution of record management systems and strategies.
• Collaborate with various departments to foster a quality-minded culture and identify innovative technologies for the records program.