Sr. QA Manager will oversee and manage activities within the QA group. This role will be responsible for Change Control Management, Documentation Management, Investigations Management, Commitment Tracking, Internal and External Audits, R&D QA Operations, Quality, Compliance, and other typical managerial responsibilities. Responsibilities include interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.
- Designee for Executive Director, Quality/ Site Quality Head.
- Communicate compliance issues to Executive Director, Quality as they arise.
- Provide guidance to QA and R&D teams on quality and compliance queries.
- Act as a liaison between all cross functional departments to resolve compliance and quality issues.
- Manage Change Control Requests (CCR). Review and approve CCRs.
- Manage Document Control Requests (DCR). Review and approve DCRs.
- Manger document control storage room and document archival.
- Review and approve standard operating procedures, instrument calibration/validation/qualification protocols and reports, methods validation protocols and reports, study protocols and reports, stability protocols and reports, investigations, extensions, and Corrective and Preventive Actions (CAPA).
- Manage investigations (non-conformance, deviations, Out of Specifications) program. Ensure timely completion of investigations.
- Ensure adequacy of investigations with respect to root cause/s analysis, and CAPA assessment.
- Track and follow-up on CAPA activities and ensure timely completion.
- Schedule and conduct Technical Review Board (TRB) meetings and related activities. Prepare and distribute meeting minutes.
- Schedule and conduct Investigation Review Board Meetings (IRB). Prepare and distribute meeting minutes.
- Prepare quality metrics/scorecards for corporate Quality Management Review (QMR).
- Ensure accuracy and completeness of the data presented for TRB, IRB, and QMR.
- Conduct internal walk-throughs of R&D facility.
- Assist and manage audits conducted by regulatory agencies, corporate quality, and consultant audits.
- Prepare responses to the corporate quality and consultant audit findings.
- Assist in writing and preparing responses to the audit findings by regulatory agencies.
- Evaluate and enhance departmental and quality systems procedures to ensure compliance with CGMPs and company policies. Prepare GAP analysis.
- Participate as a quality lead on R&D and Corporate Quality project teams.
- Prepare performance objectives and conduct performance reviews of staff.
- Prepare budget for the department. Manage within the allocated budget and resources.
- Cross-train direct reports to act as a back-up for departmental activities.
- Conduct training on SOPs, and CGMP topics as deemed necessary.
- Additional responsibilities at the discretion of Executive Director, Quality.
Company Overview Who we are?
- Bachelorâ€™s degree required; preferably in chemistry, biology, pharmacy or related scientific discipline. Masterâ€™s degree is also preferred.
- Minimum of ten (10) years of pharmaceutical industry experience in GMP QC/QA, Quality Control Laboratory (QC), or R&D Quality Laboratory Operations.
- Minimum of two (2) years of functional management/supervisory role in the GMP QC/QA, Quality Control Laboratory (QC), or R&D Quality Laboratory Operations.
- Minimum of two (2) years of experience with direct or indirect responsibility for interfacing with FDA, or directing support of associated compliance programming or commitments.
- Experience in parenteral, topical, and ophthalmic dosage forms is preferred.
- Proficiency in CGMPs in pharmaceutical environment and applicable regulatory guidances.
- Extensive knowledge of laboratory operations, quality management techniques, pharmaceutical products, and quality systems.
- Working knowledge of 21CFR Part 11 regulatory requirements.
- Excellent interpersonal, oral, and written communication skills.
- Excellent technical writing skills.
- Proficiency in English language.
- Must be able to work with a limited supervision and in a team environment.
- Ability to interact with cross-functional departments within the company including hourly, professional and management personnel.
- Requires exceptional attention to detail with the ability to focus on current assignments.
- Knowledge of computer programs such as Excel, Access, Power Point, Statistical software etc.
- Knowledge of electronic management systems such as TrackWise, Iso-Train, Master Control, Veeva Vault or similar systems.
- Ability to work on multiple projects and priorities in a concurrent manner.
- Ability to lead small and large groups in discussion and instructions.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website atwww.Akorn.com. Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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