Director, Quality Assurance

Summary

Overall responsibility for Quality Assurance and cGMP compliance activities for manufacturing sites, warehousing/distribution functions, label control and other functions/activities/systems/personnel as assigned by VP, Quality.  Provide support for compliance activities, FDA interaction, and development of strategies for continuous improvement of product quality, compliance, and performance of Operations.  Work cross-functionally to meet company objectives for high quality products delivered on-time.

Essential Duties and Responsibilities

• Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to staff members.
• Responsible for overall administration for the key QA functions and assigned personnel, including direction and support at manufacturing sites, batch record review and product release processes, label control, warehousing, and distribution systems.
• Define and lead monitoring compliance and improvements during product manufacturing.
• Identify and align priorities to deliver in line with Consent Decree commitments.
• Build capability through the use of key technical and project management tools relevant to pharmaceutical manufacturing/packaging.
• Provide hands-on technical expertise to work seamlessly with other manufacturing departments, which typically include Operations, Quality Control, Engineering, and R&D to develop and deliver new products, improve PQCD capability, and overall quality assurance.
• Direct critical cGMP systems and activities for assigned functions: NCR follow-up and completion, including final approval of deviations and NCR's prior to batch release; change control and process and cleaning validation review/approval, and continuous improvement projects.
• Establish/maintain a Site Quality Index to benchmark and measure quality initiatives to meet company and corporate operations expectations. Participate on the Quality Council, providing the QA Operations, to include the preparation, monitoring, and presentation of QA Operations metrics.
• Work with QA and Validation groups to ensure cGMP compliance in validation for product/process, cleaning and equipment.
• Provide support to the VP, Quality for identifying and achieving key company, Operations, and departmental strategies, tactics, and objectives relating to product quality and cGMP compliance.
• Assist in the broad area of in-house regulatory matters and inspections, as needed for FDA, DEA, and other regulatory agencies.
• Responsible for Quality Compliance Initiatives, CAPA implementation, and validation risk assessment.
• Investigate manufacturing failures, OOS, out of trends, frequent observations, or complaints with respective process owners.
• Prepare Deficient System Guidelines/Processes, to include review of current major systems, process mapping, formalizing technology process from R&D to manufacturing, and assist with vendor development and assessment process.
• Engineering Compliance:  assist with equipment selection and ordering process to ensure GXP compliance with respect to URS, FDS, documentation, operational fit, etc.; initiate, assist, and review approvals with VP, Quality for remediation projects for sites, new projects, and major change controls which effect critical utilities and facilities.
• Participate and approve investigations and CAPAs; review for monthly implementation in technical meeting; communicate CAPAs across organization; routinely share relevant CAPA details from other Zydus locations.
• Review and approve technical data related to stability, validation and QbD data; NOEs and deviations; process failures, and complaints and field alerts. Assess, mitigate and communicate risks, addressing with VP, Quality as appropriate.
• Work with vendors to build their QA capability to consistently deliver target quality.
• Participate on Supplier Advisory Board.
• Prepare department and individual goals that are in line with Company and departmental objectives.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals.  Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Detailed working knowledge of Quality Systems, cGMP regulations and compliance.
• Working knowledge of scale-up and technology transfer to commercial manufacturing site.
• Proven leadership, interpersonal and communication skills to effectively lead, interact, and work with all levels throughout the organization.
• Highly skilled in technical services support, process validation, change control, SOPs, batch records, technical writing, final reports, IQ, OQ, and PQ.
• Demonstrated expertise using contemporary tools to meet current and advancing cGMP requirements.
• Highly organized to effectively manage multiple priorities, projects and requirements.
• Proven skills in SPC, Minitab, statistical analysis, and process investigations.
• PC proficiency using Microsoft Office Suite required; Trackwise a plus.
• Able to travel as required for technical activities, i.e., equipment acceptance tests, vendor audits, technical seminars, investigations, product complaints, etc.

EDUCATION/EXPERIENCE

• Bachelor's degree in Pharmacy or related science required; master's preferred.
• Must have 10 years' industry experience, with five years working in pharmaceutical manufacturing in a supervisor or lead role within Quality Assurance. A background in multi-discipline departments, i.e., manufacturing, quality, projects, and/or technology transfer area preferred.
• Direct experience hosting and leading in the preparation, management, and follow-up relating to FDA inspections highly desired.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.

Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.

Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.

Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.

Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

 We are an equal opportunity employer M/F/D/V.

Current Openings for Director, Quality Assurance Jobs at Nesher Pharmaceuticals (USA) LLC