Sr. Regulatory Compliance Specialist

01 Sep, 2023


Sr. Regulatory Compliance Specialist

Wilmington, DE

About Alcami

Alcami is a world-class contract development and manufacturing organization (CDMO).  We are a team of dynamic individuals committed to developing life-saving drugs around the world.  A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve.  In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Position Summary

The Senior Regulatory Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements.  These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases.   The ideal candidate will assist with the development of SOPs or other quality documents as needed.  The position will perform the role of Lead Inspector for external audits and  act as consultant with clients for all level of regulatory issues.  The position will provide guidance and mentoring for other Regulatory Compliance employees. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

  • Performs quality review and approval of documents, data, protocols, and/or reports.
  • Performs internal and external quality audits and/or inspections.
  • Serves as a Lead Inspector for external audits.
  • Hosts client audits and inspections.
  • Hosts regulatory inspections.
  • Maintains quality databases.
  • Assists with the implementation and supports quality systems, including but not limited to vendor management, training, internal audit program, and overall regulatory inspectional readiness initiatives.
  • Assists with quality improvement initiatives as needed.
  • Consults with clients on all levels of regulatory issues.
  • Assists with development of SOPs or other quality documents as needed.
  • Maintains accurate files and records.
  • Serves as an effective member of the Regulatory Compliance team and may serve as a mentor to other Regulatory Compliance employees in area of expertise.
  • Complies with company polices and SOPs.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

  • Bachelor’s degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master’s degree in related field with 5+ years of related experience, or equivalent educational and work experience.

Alcami Non-Negotiables

  • Consistently demonstrates honesty and integrity through personal example.
  • Follows all safety policies and leads by example a safety first culture.
  • Produces high quality work product with a focus on first time right.
  • Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

  • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
  • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
  • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
  • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
  • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
  • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

  • Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
  • Good written and oral communication skills.
  • Good math skills.
  • Good computer skills and knowledge of Microsoft Office products.
  • Ability to be trained and to mentor.
  • Ability to interact well with clients and regulatory agents.
  • Ability to interact well with employees at all levels.
  • Ability to negotiate.
  • Ability to lead audits.
  • Ability to act as a consultant.

Decision Making and Supervision Required

  • Uses professional concepts and company policies and SOPs to solve a variety of problems.
  • Receives minimal instruction on day-to-day work, general instructions on new assignments.

Travel Requirements

  • Up to 5% travel required

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee 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 employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit.  The employee may be occasionally required to climb or balance.  The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration.  The noise level in the work environment is usually quiet.  The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions.  The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties.  Such personal protective equipment may include but is not limited to:  safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

What We Offer You:

  •  Competitive salary with career advancement opportunities
    •    Bonus plan
    •    Medical, dental and vision coverage from day one
    •    401(k) with company match
    •    Company paid vacation, holiday and sick-leave
    •    Voluntary benefits including short & long-term disability, life, accident, critical illness insurances

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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Job posted: 2023-09-01