The posting
Job Description
Site Quality Head in Rensselaer, NY
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.
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!
The Site Quality Head works closely with global teams in developing, implementing and maintaining corporate quality standards, policies, procedures, and processes, and control tests ensuring that the quality in site operations meet all legal, corporate, and FDA quality requirements.
Essential job duties
- Site Head of Quality provides technical, quality oversight and support to the VP of Quality Operations in making quality decisions
- 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 all products.
- Provide guidance and processes that would comply to global cross contamination control requirements
- Provide oversight and direction to the QC 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
- Drive robust site inspection readiness program, assess risks and provide guidance on compliant mitigation actions
- Direct quality and compliance process improvements and goals for the site using current regulations and demonstrated best practices.
- Support effective and efficient continuous quality and cost improvement efforts.
- Ensure 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, validations and investigations.
- Direct and manage the Quality Systems function.
- Drive improvements to Quality performance metrics
- Set and oversee data integrity standards at the site
- Includes coordination of lot release / coordination of investigations and customer relationships
- Provide plant management with data and information appropriate to reduce potential for regulatory action and assist in site productivity management. Keep plant management advised concerning agency, customer, and internal audit compliance commitments.
- Responsible to develop and maintain Quality budget on site
Supervisory Responsibilities
This position will supervise staff.
Education, experience, certification and licensures
Required
- Bachelor’s degree in Science, Chemical Engineering or related field
- Minimum 10 plus years’ experience in Pharmaceutical Manufacturing, preferably with Drug Substance commercial manufacturing facility within a regulatory environment, including 5 years in a leadership role
Knowledge, skills and abilities
- Quality System remediation and transformation experience in API or DP manufacturing facility
- Strong verbal and written communication skills
- Strong knowledge of business process needs of quality assurance
- 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, boards of directors and customers
Other Qualifications
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Pay Range: $170,000-$225,000
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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