Associate Director, Drug Product Quality (Technical Support)

We are currently looking to fill an Associate Director, Drug Product Quality (Technical Support) position. This position will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. This position is a unique opportunity to be a member of the QA Internal DP Fill/Finish management team, shaping the QA policies, programs, procedures and projects for a new state of the art start-up fill/finish site. This role will identify strategic opportunities and solutions, gaining consensus and resolving issues of quality, safety, compliance and efficiency that impact the Fill/Finish platform. You will be a part of GMP Start Up activities, including tech transfer, equipment start-up and technical training development programs. The role contributes as a member of cross-functional teams to support the Fill/Finish platform and functions as an interface between the Quality platform, Fill/Finish platform, and the Technical Community (especially Engineering/Maintenance and Manufacturing Technology). This role will also serve as a mentor and oversee junior level team members and shape the development of the Fill/Finish team.

In this role, a typical day might include the following:

• Build and execute a business strategy that translates vision and corporate goals into departmental objectives

• Builds and maintains a high performing team of technical subject matter experts and management, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Sets the course for the future- defines priorities, goals and objectives for quality team

• Provide direction, set performance standards, evaluate, develop performance and inspire direct reports

• Drives departments for optimal performance and constantly raises the bar, accountable for the performance and results of a department

• Ensure manufacturing quality staff are appropriately trained to support plant operations, ensuring risks are identified and resolved.

• Provides experienced technical guidance and support for fill/ finish related program decisions.

• Provides Project support. This position will be interface for technical transfers, engineering projects and similar activities.

• QA representative for development and approval of relevant documents including master batch records, process validations, risk assessments, product/process specifications.

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.

• Develop and deliver technical training programs.

• Provide career development and training advice. Provide regular feedback to direct reports on company and departmental operations

• Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities

• Lead cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints. Interfaces with senior management to report on project and program milestones and to present project needs

• Accountable for ensuring policies, procedures, and standards are consistently followed and adhered to on a consistent basis; and changes policies, procedures and standards as appropriate to ensure the highest quality standards are maintained

• Provides review and final QA approval of deviations, and other quality events; protocols/reports; change documentation, SOPs.

• Ensures product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned

• Responsible for representing the Company and directly interfacing with auditors during regulatory body inspections

• Ensures periodic informal audits are completed in production

• Leads teams for tracking of quality activities, metrics, CAPA tracking, etc. Reports metrics and assesses data trends to work with operating departments to facilitate process improvements

• Responsible for implementing and improving operational and strategic policies and directives

• Develops or supports program development for visual inspection, component qualification, on the floor quality, aseptic qualification, aseptic process simulation, filling batch records, assembly and pack& label, segregation/hold process

• Provide leadership and direction to the manufacturing and support area departments to ensure a constant state of inspection readiness

• Requires the ability to influence others to achieve results and to challenge the status quo

Operation Specific Tasks:

Filling:

• Develop and approve filling operation policies, process and procedures

• Train technical aspects of filling operations to the on-the-floor quality group including observance of interventions and response to atypical events (e.g. glass breakage, holes in isolator gloves)

• Serve as technical expert for filling tech transfer, start up operations, complex quality investigations and questions

• Experience with filling with isolator and RABs

• Experience with sterilization through VHP and/ or autoclaves

Visual Inspection:

• Ability to define specific visual defects and determine criticality of defect.

• Provide on-the-floor decision making as subject matter expert for operators performing visual inspection.

• Training development and oversight of visual inspection techniques.

• Experience with one or more of the following: filled liquid vials, lyophilized vials and syringes

• Experience with one or more of the following: Manual visual inspection, Automated visual inspection and semi-automated visual inspection

Pack and Label:

• Development of packaging/label inspection program including policies, process and procedures.

• Approval of packaging/label related specifications and label master records.

• Develop and define packaging/label defect documentation.

This role may be for you if you:

• Have experience with facilities start-up operations

• Understand biologics manufacturing operations

• Have good organizational skills and attention to detail

• Are able to lead cross-functional teams

To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and the following amount of experience in a Quality Operations, Quality Management or manufacturing role, in a late stage or early stage start-up Drug Product company for each level:

• Manager: 7+ years

• Sr Manager: 8+ years

• Associate Director: 10+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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