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SITE QUALITY HEAD in Hopkinton, MA

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

The Site Quality Head is directly responsible for oversight of total quality and compliance operations at the assigned site. This role uses leadership and experience to instill the highest caliber of operational excellence and guides department leadership teams in the execution of quality goals, with a focus on continuous improvement, high-quality standards, and the best-in-class customer satisfaction.

The Site Quality Head works closely with cross functional site teams, global teams in developing, implementing and maintaining corporate quality standards, policies, procedures, and processes, and control tests insuring that the quality in site operations meet all legal, corporate, and FDA quality requirements.

We proudly offer

+ Generous benefit options (eligible first day of employment)

+ Paid training, vacation and holidays (vacation accrual begins on first day of employment)

+ Career advancement opportunities

+ Education reimbursement

+ 401K program with matching contributions

+ Learning platform

+ And more!

Supervisory responsibilities

This position does have supervisory responsibilities.

Essential Job Duties

+ Site Head of Quality provides technical, quality leadership and drives Quality decisions at the site and also supports regional Director of Quality for global Quality initiatives

+ Provides hands on leadership and support in applying phase appropriate GMPs for various customer products

+ Establishes a robust program of performance metrics to measure and monitor Quality and RFT performance at the site

+ Ensures adequate manufacturing quality oversight across manufacturing and packaging operations

+ Responsible for all aspects of GMP compliance. This includes quality oversight from the point of material dispensing through final product dispatch for GMP products

+ Provide direct oversight and direction to the Microbiological and Chemistry laboratories

+ Support plant management groups on new products, changes to products, processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs

+ Acts as a key point of contact with customers for all Quality related topics, proactively works with customers to resolve Quality issues

+ Responsible for leading the effort in the transition of the site from clinical to commercial products manufacturing

+ Direct quality and compliance process improvements and goals for the site using current regulations and demonstrated best practices

+ Establish and maintain a robust site inspection readiness program

+ Use metrics to support effective and efficient quality performance and drive continuous improvement efforts

+ Ensure applicable requirements of Curia global Quality Systems are implemented and maintained in each operation throughout the facility

+ Drive accountability for all decisions made affecting product and process quality.

+ Evaluate and recommend solutions and implementation strategies for product/process issues through use of analytical, technical and leadership skills

+ Contribute to core values of Quality, Timeliness, Communication and Profitability

+ Direct and manage the Manufacturing Quality Assurance function

+ Direct and manage the Quality Control function

+ Lead site cross contamination control program

Qualifications

+ BA/BS Degree in Biology, Microbiology, Biotechnology, Life Sciences or a relevant field and a minimum 15 years of relevant related work experience in Biologics Drug Substance manufacturing, aseptic production/processing cleaning practices within a regulatory environment, OR MA/MS Degree and a minimum 10 years of relevant related work experience OR PhD and a minimum 10 years of relevant related work experience.

+ 5 years in professional management role

Knowledge, Skills and Abilities

+ Strong technical experience in Biologics manufacturing or aseptic processing

+ Strong verbal and written communication skills

+ Ability to create and maintain strong working relationships with multiple organizations, both on-site and externally

+ Strong, effective leadership skills

+ Ability to enable and empower managers and hold them accountable for results

+ Ability to create a climate of trust and cooperation

+ Exhibits strong adherence to personal and company values

+ Ability to provide strategic leadership to the organization in terms of strategy development, and provide resources and execution of defined strategy

+ Ability to read, analyze and interpret financial reports, common scientific and technical journals and legal documents

+ Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community

+ Ability to effectively present information to all levels throughout the organization, government agencies and customers

+ Prior experience as a site Quality Head at a Biologics manufacturing site would be beneficial

+ Strong knowledge of business process needs of quality assurance

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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