Director - Quality Control - Cubist Pharmaceuticals - Lexington

Job description
Position Summary:
The Director of Quality Control will provide leadership, establish policies appropriate for the function and interpret and recommend modifications to organization-wide policies and practices. This leader will effectively communicate the vision for the department as well as help articulate vision for the function. Recognize need for change, initiate and manage those changes at the department and functional level.


This individual will direct, manage, coach and develop a diverse group of direct reports, including managers and scientists, fostering a team environment that supports each other and Cubist. They will be responsible for the direction of a cGMP-compliant BioPharma QC testing and validation laboratory, oversight of GMP testing performed in the Cubist QC lab and at approved contract test laboratories and contract manufacturing organizations as well as oversight of the stability test program for late stage clinical and commercial products.

Additional responsibilities:

Collaborate with other areas to troubleshoot technical issues and contribute to defining program strategy.
Lead investigations related to QC testing issues (e.g. OOS’s) and support manufacturing organizations.
Assure product is tested in a timely manner, assuring the quality and cGMP-compliance of the QC laboratory and contract testing.
Direct continuous improvement within the Quality Control Group.
Author and review QC-related sections of regulatory filings.
Provide Alliance Partner support and management to support global regulatory and quality requirements for product portfolio.
Support Lifecycle projects to aid the extension of pipeline into other markets and support manufacturing process changes.
Assure QC representation on all clinical programs.
Assure all Cubist quality standards are met or exceeded.
Assure test method transfers are completed to meet cGMP, ICH, Cubist, et al standards and are completed to meet Cubist program timelines.
Develop strategic laboratory proposals to meet the needs of Cubist of the future.
Assist in developing Quality strategy as a member of the Quality Leadership Team.
Co-develop proposals to the Quality Specifications Committee for new test specifications.
Develop QC testing, data review and test data trending policies and procedures for Cubist.

Note: This position is not available for Visa sponsorship. Candidate must be legally authorized to work in the United States for any employer without the need for sponsorship

Minimum Basic Qualifications:

BS Chemistry, Microbiology or equivalent.
12+ years experience in a Quality Control environment in the BioPharma industry.
5+ years experience managing a BioPharma Quality Control Laboratory.

Preferred Qualifications and Experience:

Advanced degree preferred.
Experience managing both a Chemistry and Microbiology Laboratories
Experience with LIMS, ERP, Trackwise, Empower and WinKQCL
Method validation and transfers
Contract lab oversight
Knowledge of aseptic processes

Competencies:

Proactively establishes the scope of one’s decision-making ability with one’s leadership and peers to enable speedy and appropriate action in the future. Reassesses business decisions based on new information, improving processes and/or organizational structure, to enable successful implementation of business plans.
Provides ongoing clarity as needs change, keeping the team aligned with changes both in the external environment and across Cubist as an enterprise. Follows up to ensure that people have what they need to succeed.
Provides feedback to team members on an ongoing basis, so people know how they are doing against outcomes. When needed for the business, takes decisive action to remove or replace team members who do not improve performance. Continually raises standards of performance across the organization and communicates these expectations.
Makes Cubist-wide changes to systems and processes in order to drive strategy and performance across the enterprise, committing significant resources and/or time to improve outcomes for the business and for other stakeholders.
Engages the hearts and minds of key stakeholders, making one’s argument/point of view relevant to them by connecting with others’ emotions.
Demonstrate the ability to communicate clearly, concisely, and effectively to express information in both written and oral context.

Work Environment:

Office
Laboratory
Some travel required, likely not to exceed 10%.

Physical Demands:

Must be able to lift 10 pounds easily.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions .

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