Director Continuous Process Improvement

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POST DATE 8/25/2016
END DATE 12/19/2016

A Biotech and Pharma Company Allston, MA

Allston, MA
AJE Ref #
Job Classification
Full Time
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Director Continuous Process Improvement


The primary responsibility of the Operational Excellence organization is to instill a culture of continuous improvement in the Facility, ensure site-wide continuous improvement momentum through the education, motivation, engagement and empowerment of all employees by deploying sound change management tools and practices, as well as rigorous project disciplines, within a framework of planned transition.


The position provides vision, leadership and tactical coordination for the overall operational transformation program.

Key Responsibilities: Establishes long range operating, project and transformation plans and sets near term priorities, goals and objectives for the operational excellence area of responsibility in consultation and coordination with Site Management.

Allocates human resources and selects, acquires and deploys appropriate methodologies to fulfill near term goals and commitments while building towards sustainable operational excellence. It is the responsibility of this position to motivate and lead his/her organization according to our company's policies to achieve business objectives that will have a major impact on the success of the Corporation.

Specific cGMP Responsibilities: Provide direct oversight of the Operational Excellence organization: Ensure all personnel, including contractors, consultants and temporary employees who work in department and directly or indirectly support cGMP activity, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations; Ensure individual training/learning plans are kept current and that employees complete and document all required initial and continuing training in accordance with the Corporate Quality Standard for Training; Ensure that all activities and actions designed or carried out by personnel involved in a project or continuous improvement event are devised or carried out within the proscribed Facility procedures and the Corporate Quality Standards.

General Responsibilities: Active member of Management Team with the shared responsibility of supporting and/or leading specific efforts to enable the sustaining of a reliable patient supply while addressing Consent Decree requirements including remediating Quality Systems, upgrading the facilities and equipment and establishing capable, compliant manufacturing processes for Cerezyme and Fabrazyme. Use Operational Excellence (OE) and lean enterprise principles and resources to drive rapid and effective change.

Put in place required operational and informational management decision support systems to establish and maintain a culture of execution and continuous improvement. Lead the OE organization and ensure that capabilities are in place to deliver against goals and commitments. Monitor, report and assure transparency of performance throughout organization.

Establish departmental and individual goals and objectives in alignment with site goals and priorities. Identify performance improvement targets and metrics. Ensure capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets. Strengthen overall leadership and organizational capabilities in area of responsibility.

Build and sustain high performance management team and ensure strong alignment and coordination with other functional groups at the site. Identify the required resources and expertise, implement the appropriate team/departmental structures and establish the required processes and communications to enable department(s) to effectively deliver on all commitments.

Ensure effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility. Manage headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.

Motivate, retain and develop key employees. Build and sustain employee engagement by creating a culture of execution and an environment within which individuals and teams can excel and continuously improve.

*Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

LEADERSHIP QUALIFICATIONS: N/A if this position does not have direct reports Leading People Our company's leaders motivate and inspire their people and build effective teams. They manage for high performance and develop others within the organization. Our company's leaders are versatile learners who are comfortable with complexity and ambiguity.

They are courageous decision makers who are candid and direct. Leading the Business Our company's leaders understand and respond to the evolving business environment. They think beyond their sphere of influence to see what is not obvious, and create a compelling vision and direction that inspires engagement from their people.

Our company's leaders continuously look internally and externally for best practices. They challenge the status quo and encourage their people to try new approaches.

They have a track record of generating successful new ideas that improve business performance. Delivering to Customers Our company's leaders understand the patient and customer viewpoint.

They build trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good. Our company's leaders set ambitious and realistic targets, drive for results, and build accountability within the organization. They set high standards and continuously improve.


Bachelor's Degree in the Life Sciences or Bio/chemicalEngineering and at least 12years of progressive operational/change management leadership experience or equivalent. Or Master's Degree in the Life Sciences or Bio/chemicalEngineering and at least 10years of progressive operational/change management leadership experience or equivalent.


Progressive management experience in at least one other core functional area (Manufacturing, Quality) is ideal. In-depth knowledge of biopharmaceutical cGMP manufacturing operations.

Demonstrated ability to mentor leadership teams and devise and deploy strategic change initiatives with significant business results.

Demonstrated and recognised ability to select and successfully deploy appropriate change methodologies and management decision support systems.

Demonstrated ability to develop self; build high performance teams and develop others. Excellent communication skills and ability to influence and build relationships across the broadest constituencies both internal and external to the site.

Excellent people leadership and change leadership skills.

Excellent problem solver and abple to generate innovative solutions to broad range of issues. Knowledge of cGMP manufacturing operations.

Ability to set ambitious and realistic targets, drive execution and build culture of continuous improvement and accountability.

SPECIAL WORKING CONDITIONS: N/A Ability to gown and gain entry to manufacturing areas.


Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Commission Compensation - Yes
Bonus Eligible - Yes

Candidate Details

* 10+ to 15years experience

Management ExperienceRequired - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally

Additional Details
Location: Allston
Industry: Pharmaceutical / Biotech
Job Category: Research & Development
Hours Per Week: 40
Visa Candidate Considered: No