Job Description

STA is constructing new facilities to manufacture small molecule drug products. This will include capabilities for oral solid as well as sterile dosage forms manufacturing. As well as the supporting analytical, warehousing and other needed capabilities. The position will initially lead the team (including consultancy firms) responsible for the quality and compliance support during design, construction and qualification phases of these facilities. And will be responsible for the implementation of the quality system.

After start of operations and manufacturing, this position will take overall quality leadership responsibility, managing the QA team supporting the Quality system, Product release and continuous quality.

The individual will keep close cooperation with the Site Leadership Team, and will develop the Quality assurance team to support the creation of a culture that aligns with the Company’s core values of integrity & dedication, working together, doing the right thing, and doing it right. The position will ensure compliance with all Company, local, state, and federal policies and procedures and international authority requirements for quality and compliance.

This position has the flexibility to be hired at either the Director or Senior Director level dependent upon candidate experience and business needs.

100% Onsite in Middletown, DE.

• Manage a team of Quality professionals and compliance consultants, including oversight of quality processes and systems at the site.
• Manage resource plan for both internal and external resources to support the site project plans. This includes allocation of resources to projects and activities to ensure compliance with quality requirements and timelines.
• Recruit new staff and ensure that they receive proper qualification and training, including EHS training and IP protection policies. Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work.
• Continuously coach, develop, monitor, and appraise direct reports, including performance management, goals & job results.
• Provide leadership and quality qualification guidance to support the successful execution of design, construction and qualification of the new facilities along with future engineering projects.
• Develop and implement a quality system to meet regulatory requirements and customer expectations.
• Review and approve facility and equipment qualification documentation and quality system documentation to support ongoing site projects.
• Lead and/or supervise quality issue resolution in a timely manner to ensure smooth progress of the site projects. This includes implementation of solutions and preventive actions
• Host or assist during Health Authority inspections and ensures successful completion of these inspections
• Host or assist during Client audits and ensures successful completion of these audits.
• Organize Quality management reviews to drive quality and continuous improvement. Report significant quality issues to senior management.
• As needed, drive customer communication and drive customer satisfaction.
• Interface with other Site Leaders to coordinate quality and compliance activities
• Contributes to the overall operations and to the achievement of Site goals and objectives.
• Performs job-specific tasks in compliance with applicable Regulations, International Standards, and Company Policies and Standard Operating Procedures.
• Demonstrates thorough understanding of, and implements, Good Manufacturing Practices.
• Other duties as assigned.

Experience / Education

• Bachelor’s degree in Pharmaceutical, Chemical or analytical sciences, Master’s and PE preferred or equivalent experience
• Minimum 10+ years of relevant experience or equivalent in pharmaceutical quality assurance and/or facility and equipment qualification. Including proven ability in people leadership and team development
• Proven Quality leadership experience in a CDMO environment preferred
• Be proficient in pharmaceutical manufacturing processes (drug substance and drug product) and GMP regulations.  

Knowledge / Skills / Abilities:

• Strong hands-on leadership style
• Proficient in oral & written communication skills
• Demonstrated ability to read, write and speak English
• Proficient in Microsoft Office (Excel, Word, Outlook)
• 20% travel is required; both domestic and international

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions
• Must be able to wear appropriate PPE
• Must be able to work in an environment with variable noise levels
• Ability to stand/sit/walk for long periods of time
• Ability to lift 10 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 10 lbs. routinely / often / occasionally
• Clarity of vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb ladders / stairs / scaffolding
• Ability to work in variable temperatures (hot, cold, etc.)
• Ability to work both inside and outside in varying working conditions

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

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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