Associate Director, QA Manufacturing

Athenpollo is looking for an Associate Director, Downstream QA Manufacturing to support a global pharma company. This is a full-time position close to Bridgewater, NJ. Security, Satisfaction, flexible working hours, and Happiness, come along with a handsome package!

Job title: Associate Director, Downstream QA Manufacturing.
Location: close to Bridgewater, NJ.
Job type: Full-time permanent.

Job Description:

• This position will provide guidance and direction for day-to-day quality activities ensuring GMP compliance supporting the downstream purification operations at the company. Examples of day-to-day activities include partnering with the business to resolve critical and/or complex compliance issues, ensuring procedures are aligned with global quality standards and regulatory expectations while remaining consistent across multiple business areas, assuring data integrity with paper based and electronic processes, overseeing the implementation of risk-based strategies, leading operational excellence initiatives including productivity and process improvements with significant impact to the quality organization and across the site, ensuring the site is inspection ready at all times, interacting with FDA and other regulatory/health agencies when necessary.
• This position represents QA downstream purification on the Quality Lead Team and other forums as per the company's Manufacturing Standards for Operational Excellence (MSOE). Additionally, this position guides/develops staff, provides strategic direction for their area of responsibility, creates organizational plans, and defines yearly departmental objectives.

Responsibilities:

• Promote a positive Quality Culture and oversee on-the-floor Quality presence in the respective business area (e.g., manufacturing).
• Provide Quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.
• Oversee data integrity for paper based and electronic systems, including Quality review of audit trails. 4. Ensure compliance with applicable the company's global standards and regulatory guidelines (e.g., 21 CFR Part 11 related to computer systems).
• Evaluate and approve change controls, risk assessments, excursions, and deviation investigations. Recommend CAPAs and ensure CAPAs implemented are effective. Ensure that Quality System related changes/deviations are evaluated consistently.
• Prepare site for regulatory inspections. Host regulatory and business partner inspections/audits and coordinate inspection/audit responses and commitments.
• Review/approve standard operating procedures, batch records, specifications, validation protocols/reports, instrument acquisitions/decommissions, job plans, work orders, as applicable. Ensure processes are harmonized across multiple business areas.
• Serve as key Quality resource on Lead Teams and/or other forums as required and provide compliance guidance to Manufacturing, QC, FUME and other supporting business units.

Required skills:

• BA/BS degree in Chemistry, Biology, Computer Science, Engineering, or a science related field, as applicable.
• Requires a minimum of 5 years technical and/or Quality experience (i.e., production, validation) in a GMP regulated environment, Biopharmaceutical industry preferred.
• A minimum of 2 years of management/leadership experience is required.
• A minimum of 1 year of experience supporting protein purification processes or technologies (i.e., laboratory, development large scale).
• Influences internal/external customers and senior management, has the capability to identify and solve a range of organizational and operational problems and technical challenges, able to proactively remove barriers, and influence a positive Quality Culture.
• Must have a thorough understanding of data integrity, computer systems validation per CGMPs, and an understanding of System/Software Development Lifecycle concepts.
• Must have experience in leading medium/large scale process improvement projects.
• Must be proficient in Microsoft applications and quality systems.

Contact: Ismail
Email: ismail(AT)athenpollo.com

About Us:
AthenPollo is a fast-growing and dynamic organization providing IT & Non-IT consulting and staffing services for over 10 years and is committed to becoming one of the nation’s premier IT companies. Our highly skilled and experienced team strives to deliver the highest levels of service and value to our Customers and Consultants. Our client base is comprised primarily of Fortune 100 companies and large system integrators.

Job Type: Full-time

Pay: $150,000.00 - $180,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Relocation assistance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Education:

• Bachelor's (Preferred)

Experience:

• Quality: 6 years (Preferred)
• Biopharma: 2 years (Preferred)
• Protein purification: 2 years (Preferred)
• CGMP: 1 year (Preferred)

Work Location: In person

Salary : $150,000 - $180,000