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We are seeking an accomplished Manufacturing Change Control Manager to spearhead change control initiatives for our upcoming external manufacturing facility in Boston. Your role will be pivotal in ensuring the smooth integration of new manufacturing processes and protocols while upholding stringent compliance standards. As the bridge between various stakeholders, you will harness your exceptional soft skills to facilitate effective change control processes, foster a culture of quality, and ensure seamless collaboration across functions.

• Lead, strategize, and execute comprehensive change control processes for the implementation of new manufacturing processes and protocols in our new external facility.
• Collaborate extensively with cross-functional teams, including operations, quality assurance, regulatory affairs, and engineering, to align change control activities with regulatory requirements and internal quality standards.
• Champion regular meetings with key stakeholders to gather insights, communicate progress, and address challenges tied to change control endeavors.
• Instill a compliance-centric ethos by meticulously adhering to industry regulations, guidelines, and organizational protocols throughout the change control process.
• Establish and uphold meticulous documentation and records for change control undertakings, ensuring their accuracy, accessibility, and compliance-readiness for audits and assessments.
• Cultivate strong partnerships with quality assurance teams, enabling rigorous evaluation and endorsement of change requests.
• Initiate and drive continuous improvement efforts by analyzing change control protocols, identifying efficiency opportunities, and adapting processes to enhance both agility and compliance.
• Serve as the resident authority on change control processes, providing guidance to cross-functional teams on optimal practices and ensuring a uniform approach.
• Demonstrate a proactive stance toward risk management, promptly identifying potential bottlenecks and devising effective mitigation strategies.
• Contribute actively to the development and delivery of training programs centered around change control processes and compliance measures.

REQUIREMENTS

• Bachelor's degree in a relevant field (engineering, life sciences, or related discipline).
• Demonstrated expertise in change control management, preferably within the pharma sector, with a focus on external manufacturing.
• Exceptional interpersonal and communication proficiencies, pivotal for effectively engaging stakeholders at various organizational tiers.
• Innate ability to facilitate collaboration, foster consensus, and guide multifunctional teams through transformative change initiatives.
• Proficiency in problem-solving, critical analysis, and decision-making within intricate and dynamic contexts.
• Familiarity with pertinent industry regulations and guidelines, including FDA, cGMP, and ISO standards.
• Previous exposure to close collaboration with quality assurance units and deep comprehension of compliance requisites.
• Strong attention to detail, accompanied by excellent organizational and documentation skills.
• Agility and adaptability to thrive in a fast-paced startup environment marked by continuous evolution.
• Positive outlook, coupled with a resolute "go-getter" attitude

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